CrawlJobs Logo

LIMS Implementation Specialist

United Kingdom, Manchester · Job Posted January 10, 2026
Apply Position
Job Link Share

Job Description

Our Implementation Specialists work with Project Managers, SMEs and our customers to deliver Evolution vLab®. The position may require on-site working across multiple implementation sites in the United Kingdom.

Job Responsibility

  • Leads customer design and configuration, scopes and documents customer requirements via design workshops
  • Supports insight into clients’ needs to Project Manager
  • Leads the process mapping of current state to future state workflows as appropriate
  • Supports business and function requirements and functional design specifications with Product Application Specialists
  • Identifies and escalates risks and issues relating to design, developing and researching options for remediation or mitigation where appropriate
  • Works with cross functional client teams to ensure requirements, functional and design specifications are understood and accepted by all internal stakeholder groups
  • Supports development and testing teams during development and testing phases
  • Ensures any solution proposed meets all UK regulatory standards and requirements
  • Ensures project activities and documentation conform to relevant quality standards
  • Assists with pre-sales activities

Requirements

  • Degree in Biomedical Science / relevant Clinical Field or Information Technology field (Desirable)
  • PRINCE2 or APMG qualifications an advantage
  • Change Management qualification will be highly regarded
  • Proven work experience as a Business Analyst or similar in health technology
  • Experience in or with a pathology laboratory
  • Use of Visio or equivalent for process mapping
  • Use of laboratory information management systems
  • A sound understanding of the professional, ethical and legal requirements that underpin the health informatics environment
  • Good understanding of laboratory Health and Safety, CPA, MHRA EU Blood Directive and MHRA Good Clinical Practice for Laboratories and other relevant regulations and standards

Nice to have

  • Ability to gather and document high quality requirements
  • Passionate about excellence, technology and management and seek to be the best in their field
  • Strong interpersonal skills with excellent problem-solving skills
  • Ability to prioritise duties, including the effective and efficient planning and management of a complex workload to meet competing deadlines
  • Ability to communicate scientific/technical information with all levels of the organisation

What we offer

  • Hybrid working environment from Manchester (City Centre) or London (Farringdon) – 3 days a week from the Office and 2 from home
  • 25 days (increases with length of service up to 4 days) plus 8 bank holiday
  • Holiday purchase scheme via salary sacrifice
  • An extra day annual leave for your birthday
  • Enhanced Maternity Leave
  • Enhanced Paternity Leave
  • Religious holiday swap programme
  • Up to two days paid Volunteering days
  • Paid time off during the working day to donate blood
  • Pawrental Leave
  • Litmos learning
  • Product Training
  • Peer recognitions
  • CEO awards
  • Length of service awards
  • Performance Annual Bonus Programme
  • Life Insurance (4x annual salary)
  • Private health care (BUPA) plus discounted rates to add your loved ones
  • Salary Sacrifice Pension
  • Income Protection
  • EAP (access to online Healthcare)
  • Employee Referral scheme- £1,000 tax free
  • Branded merchandise starter pack
  • £250 working from home allowance
  • Free Flu Jabs
  • Enhanced Sick Pay

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

LIMS Implementation Specialist

8 matching positions

Specialist Qc Compliance

Role Overview: Specialist QC Compliance The Specialist QC Compliance acts as a S...
Location
Location
Switzerland , Yverdon-les-Bains
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
July 31, 2026
Flip Icon
Requirements
Requirements
  • MSc in Biotechnology, Pharmaceuticals, Engineering, or equivalent industry experience
  • Minimum 5 years in a GMP environment, with at least 3-5 years specifically in Quality Control
  • Deep expertise in quality systems (Deviations, CAPA, Change Controls), hands-on equipment software qualification, and strong troubleshooting abilities
  • Proactive, rigorous, and team-oriented with a proven ability to build trust and work in highly regulated environments
  • Fluent in both French and English (C1 level or equivalent)
Job Responsibility
Job Responsibility
  • Oversee, document, investigate, and close quality events
  • Ensure the timely execution of deviations, root cause analyses, CAPAs, change controls, and periodic reviews
  • Coordinate the QC Data Integrity Plan, conduct risk assessments, implement mitigations, and deliver data integrity training to the team
  • Support the qualification and validation of QC equipment and related software (URS, protocols, risk assessments, reports)
  • Track equipment work orders, maintenance, and calibration records
  • Assist with QC sample management (reception, aliquoting, LIMS entry), material release, and monthly reviews of environmental monitoring system (EMS) alarms
  • Author, review, and maintain SOPs and related quality documents
  • Participate in audit/inspection readiness and address any observations
  • Monitor and coordinate the implementation of regulatory and pharmacopoeial updates
  • Fulltime
Read More
Arrow Right

Manufacturing Execution System (MES) Engineer / MES Software Specialist

We are seeking a skilled MES Engineer to bridge the gap between Manufacturing Op...
Location
Location
Switzerland , Hinwil
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 31, 2026
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Information Technology, Software Engineering, Industrial Engineering, Automation Engineering, or a related field
  • 3–8 years of experience in MES, Manufacturing IT, Industrial Software, or Digital Manufacturing environments
  • Experience supporting MES platforms such as Siemens Opcenter, Rockwell FactoryTalk ProductionCentre, AVEVA MES, Dassault DELMIA Apriso, SAP ME/MII, Critical Manufacturing MES, GE Proficy Plant Applications
  • Strong understanding of software development principles
  • Experience with SQL Server, Oracle, PostgreSQL, or similar databases
  • Knowledge of REST APIs, web services, and system integration technologies
  • Experience with C#, Java, .NET, JavaScript, Python, or similar programming languages
  • Familiarity with manufacturing communication protocols such as OPC UA, MQTT, and Modbus
  • Understanding of software testing, deployment, and version control processes
Job Responsibility
Job Responsibility
  • Design, configure, develop, and maintain MES applications to support manufacturing operations
  • Analyze business requirements and translate them into MES system solutions
  • Configure workflows, electronic work instructions, production routing, and quality processes within the MES platform
  • Provide ongoing application support, troubleshooting, and root-cause analysis
  • Develop and maintain integrations between MES and enterprise systems including ERP, PLM, WMS, LIMS, and SCADA
  • Collaborate with automation engineers to connect shop-floor equipment, PLCs, and IoT devices
  • Ensure reliable real-time data exchange between manufacturing and business systems
  • Support API, web services, and middleware-based integrations
  • Manage manufacturing master data, production data, and system configurations
  • Develop SQL queries, reports, dashboards, and KPIs for production monitoring
  • Fulltime
Read More
Arrow Right

Senior Quality Validation Specialist

Leading Global Pharmaceutical Multinational (MNC) is seeking a high-caliber Seni...
Location
Location
Singapore , Singapore
Salary
Salary:
7000.00 - 9500.00 SGD / Month
https://www.randstad.com Logo
Randstad
Expiration Date
July 19, 2026
Flip Icon
Requirements
Requirements
  • Minimum of 5 years of robust experience in a highly regulated pharmaceutical or biopharmaceutical manufacturing environment
  • At least 3 years of dedicated track record in successfully delivering validated laboratory systems qualifications
  • Strong hands-on experience and structural understanding of automated systems and computerized system validation (CSV) frameworks supporting lab or plant operations
  • Proven ability to work independently, influence cross-functional teams, and deliver results under tight project schedules
  • Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, and/or laboratory operations
  • A Bachelor’s Degree or Diploma in a relevant technical or scientific discipline
Job Responsibility
Job Responsibility
  • Lead and oversee the preparation, review, and execution of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ) for complex automated and computerized systems
  • Provide deep, hands-on expertise in the qualification of automated systems supporting manufacturing (e.g., PLC/SCADA, MES) and/or advanced laboratory operations (e.g., LIMS, Empower, instrument software integrations)
  • Ensure all validation activities strictly comply with global Good Manufacturing Practices (GMP), GAMP 5 methodologies, and stringent Data Integrity standards (21 CFR Part 11 / ALCOA+ principles)
  • Partner closely with Automation, IT, Quality Control, and QA teams to manage project timelines. Drive risk assessments (FMEA) and proactively mitigate validation delays
  • Provide senior-level oversight for validation deviations. Lead thorough root-cause investigations and implement robust Corrective and Preventive Actions (CAPA)
What we offer
What we offer
  • SGD 250 Monthly Transport Allowance
  • Fulltime
Read More
Arrow Right

Empower Automation Specialist

Do you have a passion for combining analytical methodologies with cutting-edge a...
Location
Location
Netherlands , Leiden
Salary
Salary:
3502.00 EUR / Month
https://www.randstad.com Logo
Randstad
Expiration Date
April 07, 2027
Flip Icon
Requirements
Requirements
  • You hold a Bachelor's degree (HBO) in Life Sciences, Computer Science, or possess equivalent experience in a similar role
  • You have a minimum of 2 years of experience in the pharmaceutical industry with dedicated GMP and automation responsibilities
  • You have hands-on experience in software development and validation
  • previous laboratory experience or Computer System Validation (CSV) is a major plus
  • You possess demonstrable experience with Empower in a GxP environment, preferably including custom fields
  • You have excellent written and verbal English communication skills (Dutch is a nice-to-have)
  • You are familiar with, or eager to work with, systems such as SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, Comet, GAMP 5, 21 CFR Part 11, or Lean/Six Sigma methodologies.
Job Responsibility
Job Responsibility
  • Leading the technical implementation of new Empower projects for analytical instruments (ranging from HPLCs and UPLCs to PA800s) alongside cross-functional teams
  • Implementing and maintaining Empower solutions while actively identifying opportunities to switch to paperless workflows
  • Creating and maintaining administrative, technical installation, and maintenance procedures
  • Taking full ownership of data integrity practices, including backup strategies and disaster recovery planning
  • Providing timely support, software validation, and troubleshooting for computerized system challenges as part of the core support team
  • Delivering validated methods to laboratories to enable innovative testing approaches for new products
  • Participating in laboratory systems initiatives and projects in close cooperation with our global organization.
What we offer
What we offer
  • Salary starting at € 3502(exp. based)
  • Year contract with chance of extension
  • Free public transport(NS business card)
  • Innovative and international work environment
  • Learning & Development opportunities
  • 36 vacation days a year!
  • End-of-year bonus
  • Unlimited access to free online training courses
  • NS Business Card for all your travel
  • Fulltime
Read More
Arrow Right

Specialist, QC Systems

As the Specialist, QC Systems, you will support the design, implementation, and ...
Location
Location
Canada , Vancouver
Salary
Salary:
76000.00 - 95000.00 CAD / Year
abcellera.com Logo
AbCellera Biologics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
  • Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
  • Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
  • Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
  • Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
  • Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills
Job Responsibility
Job Responsibility
  • Supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
  • Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
  • Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
  • Supporting the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
  • Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
  • Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
  • Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
  • Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
  • Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
  • Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes
What we offer
What we offer
  • Equity
  • Annual bonus dependent on team and company performance
  • 6% (non-match) RRSP contribution
  • CAD $1,500 annual Active Lifestyle Allowance
  • Annual vacation
  • Professional development opportunities
  • Comprehensive health benefits
  • Scientific and technical mentorship
  • Strong sense of community and connections through work, clubs, and socials
  • Fulltime
Read More
Arrow Right

Solutions Architect

We are seeking an experienced SAP Solution Architect to spearhead the Plan to De...
Location
Location
United States
Salary
Salary:
152000.00 - 209000.00 USD / Year
biomarin.com Logo
BioMarin Pharmaceutical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Business, Information Technology, Engineering, or a related field
  • advanced degree preferred
  • 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes
  • Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management)
  • experience with SAP S/4HANA is a plus
  • Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment
  • Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes
  • Experience with in-house and contract manufacturing workflows, including batch management and material traceability
  • Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar
  • Strong analytical, problem-solving, and communication skills to bridge business and technical teams
Job Responsibility
Job Responsibility
  • Solution Design, Implementation & Integration: Responsible for designing, describing, and managing SAP solution design of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Deliver processes, including production planning, shop floor execution, quality management, and material management
  • Facilitate integration between SAP and boundary applications (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing, quality operations, and warehouse processes
  • Collaborate with cross-functional teams and business stakeholders to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA) and upholding “fit to standard” design principles in alignment with organizational goals
  • Develop and maintain functional specifications, process flows, integration plans and system configurations to ensure PTD processes scalability, reliability, and performance
  • Review configurations and deployments to maintain quality standards
  • Create clear, concise decision rationale documents balancing innovation with practicality, considering factors like cost, support, and compatibility with global end to end designs
  • Effectively communicate complex technical concepts to non-technical stakeholders and multifaceted business processes to technical stakeholders
  • Manufacturing Support: Support both in-house and contract manufacturing operations by configuring SAP solutions to manage production schedules, capacity planning, and material traceability
  • Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes
  • Quality Control & Assurance: Oversee the implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment
What we offer
What we offer
  • company-sponsored medical, dental, vision, and life insurance plans
  • paid time off
  • discretionary annual bonus
  • discretionary stock-based long-term incentives
  • Fulltime
Read More
Arrow Right

IT Quality-Specialist

Join Amgen’s Mission of Serving Patients. In this vital role you will lead the e...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance
  • Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience
  • Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards
  • Proven experience in the validation of computerized systems (GxP)
  • Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP)
  • Experience managing quality assurance processes, including Major and Minor Deviations
  • Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills
  • Strong decision-making abilities with the capacity to drive tasks to completion
  • Ability to work independently with minimal supervision
  • Leadership skills with experience leading projects, teams, or tasks
Job Responsibility
Job Responsibility
  • Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures
  • Supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation
  • Actively participate during all phases of qualification/validation of computerized systems: evaluate projects
  • provide guidance and technical information to others (lead qualification/validation activities)
  • determine and establish requirements for qualification/validation of each individual system/equipment
  • formulate independent decisions related to qualification/verification activities
  • Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis
  • Serve as Owner or QA Contact for Minor and Major Deviations
  • Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations
  • Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes
What we offer
What we offer
  • Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Read More
Arrow Right

Quality Assurance Manager - CLIA/CAP Laboratory

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cu...
Location
Location
United States , Pleasanton
Salary
Salary:
132800.00 - 179600.00 USD / Year
10xgenomics.com Logo
10x Genomics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or related field
  • 10+ years of experience in quality assurance within a regulated clinical laboratory (CLIA/CAP environment)
  • Demonstrated experience building or expanding quality systems in a CLIA lab setting
  • Strong working knowledge of CLIA / CAP quality and documentation requirements
  • Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred
  • Experience preparing for and leading CAP inspections and CLIA audits
  • Excellent written and verbal communication skills, with an ability to collaborate across scientific, operational, and regulatory functions
  • Hands-on, proactive, and adaptable, capable of working effectively in an early-stage, fast-growing diagnostic environment
  • Experience with LIMS, electronic QMS tools, and training management systems is required
Job Responsibility
Job Responsibility
  • Clinical Quality Framework Establishment and Oversight: Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations
  • Collaborate closely with CLIA and assay development teams to develop and manage SOPs and work instructions
  • Partner with the broader Quality/Regulatory team to integrate the CLIA lab’s quality infrastructure into 10x’s enterprise-wide quality management system (QMS)
  • Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
  • In partnership with CLIA Lab Director, ensure inspection readiness and execute regulatory submissions (CLIA, CAP, and state licensure)
  • Operational Quality Support: Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
  • Serve as QA reviewer/approver for method validation, verification, and change control documentation for both laboratory methods and assay software components
  • Ensure effective management of reagents, instruments, and workflow changes per CLIA/CAP requirements
  • Support onboarding and verification of LDTs transferred from Diagnostic Assay Development teams
  • Act as quality liaison with external auditors and partners
What we offer
What we offer
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing
  • Family friendly policies like parental leave
  • Award-Winning Workplace
  • Fulltime
Read More
Arrow Right