CrawlJobs Logo
360 Resourcing Solutions Logo 360 Resourcing Solutions · Manufacturing

Cqv Engineer

United Kingdom, Keele · Job Posted March 01, 2026
Apply Position
Job Link Share

Job Description

The CQV Engineer (Commissioning, Qualification, and Validation) will primarily be accountable for the qualification and validation for Processes, Facilities, Equipment, and Computer System Validations in a Medical Device (cGMP) environment.

Job Responsibility

  • Validation Activities: Organise and perform validation activities to provide an effective validation service
  • Compliance Documentation: Ensure all required documentation for a validation exercise, including validation protocols and summary reports, are created and maintained
  • SOP and Documentation Support: Provide input and technical expertise for the creation and revision of relevant Standard Operating Procedures (SOPs) and other quality \ Validation documentation
  • Project Alignment: Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans, objectives and schedules
  • Compliance Assurance: Ensure design projects relating to processes, facilities, equipment, and Computer System Validation are in compliance with regulatory and company requirements
  • Expert Advice: Provide validation support and advice to operations and other areas of the business as required to ensure that all operations are carried out in compliance with regulatory and company requirements
  • Specialist Knowledge: Provide specialist knowledge on validation of
  • process, facility, equipment and application of computer systems used within production and service
  • Continuous Improvement: Support a continuous improvement culture within the business

Requirements

  • Level 6 within a science regulated industry or relevant experience
  • Minimum 3 years Validation experience within Pharmaceutical/Medical Devices, including cleaning, analytical methods, lab equipment, and computer system validation and re-qualification
  • Creation of validation protocols and reports
  • Knowledge of Quality Management Systems
  • Comprehensive knowledge and experience with the following industry regulations and guidance: FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices), ISO 13485:2016 (Medical devices - Quality management systems), ALCOA+ principles for Data Integrity (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), ICH Q9 (Quality Risk Management) and its application to validation/qualification
  • Excellent communication skills
  • Ability to meet deadlines
  • Attention to detail
  • Demonstrate positive and enthusiastic attitude

Nice to have

  • Manufacturing process validation experience preferable, including validation of new processes and changes to established processes using the lifecycle approach to validation
  • Proficient in Kneat or other alternative system and software packages
  • People management skills
  • Full, clean driving licence
  • Occasional overtime requirements

What we offer

  • Company events
  • Company pension
  • Employee discount
  • Free or subsidised travel
  • Free On-site parking
360 Resourcing Solutions - All Job Offers

Looking for more opportunities?

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

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Cqv Engineer

8 matching positions

CQV Engineer

We are looking for multiple CQV Engineers to join our Life Sciences team to supp...
Location
Location
United States , Boston, MA and Southern NH areas
Salary
Salary:
Not provided
amts.com Logo
AM Technical Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3+ years professional experience in a biologics/pharmaceutical
  • Experience developing and executing process, equipment, and validation protocols
  • Knowledge of cGMP practices and standards
  • Excellent written and verbal communication and interpersonal skills
  • Bachelor’s degree (preferably in an engineering discipline) or relevant scientific or related discipline
Job Responsibility
Job Responsibility
  • Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes
  • Start-up C&Q experience of process and utility systems
  • Work as part of a large project team and be a system owner for a system
  • Author and execute CQV documentation for a defined system against project schedule and timelines
  • Deviation/Nonconformance write up and close out resolution
  • Provide direction, input, review and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems, and utilities
Read More
Arrow Right

Lead Engineer CQV

Discover your exciting role. Exyte is a global leader in design, engineering and...
Location
Location
Germany , Nürnberg
Salary
Salary:
Not provided
exyte.net Logo
Exyte Central Europe GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in Biotechnology, Pharmaceutical, Building Services Engineering or Process Engineering or related field
  • Several years of experience in CQV within life sciences industry, including leadership responsibilities
  • Strong knowledge of GMP, ISO, 21 CFR, Annex 15, data integrity
  • Proven ability to lead teams and manage complex projects
  • Fluent German and good English skills required
  • High level of quality awareness, efficiency, and accuracy
Job Responsibility
Job Responsibility
  • Lead and mentor CQV engineers, ensuring efficient resource allocation and professional development
  • Define CQV strategies and ensure alignment with project objectives, timelines, and compliance requirements
  • Supervise commissioning, qualification, and validation activities for HVAC, cleanroom, and clean media systems according to GMP regulations
  • Approve CQV documentation (specifications, risk analyses, protocols, reports) and ensure regulatory compliance
  • Act as primary interface between CQV team, clients, technical engineering, automation, QA, and suppliers
  • Oversee FAT/SAT activities and review supplier documentation
  • Implement best practices and drive process optimization across projects
What we offer
What we offer
  • Your Start at Exyte: Join a two-day onboarding event with new colleagues
  • Attractive Location: Spacious workspaces with height-adjustable desks
  • Buddy System: Several weeks of onboarding with your teammates
  • Work-Life Balance: Option to switch to mobile working at any time
  • Catering: Free specialty coffees and water dispensers on every floor
  • Stay Fit: Exyte subsidizes your fitness membership via Qualitrain at over 5,000 locations across Germany
  • Fulltime
Read More
Arrow Right
New

Senior Engineer CQV

Shape innovative projects in the pharmaceutical industry and take on responsibil...
Location
Location
Switzerland , Basel
Salary
Salary:
Not provided
exyte.net Logo
Exyte Central Europe GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Degree in engineering, natural sciences, or a pharmaceutical-related field
  • Willingness to travel within Switzerland
  • Strong knowledge of GMP regulations and common industry standards
  • High level of quality awareness and attention to detail in documentation
  • Several years of professional experience in the pharmaceutical industry
  • Very good German and good English skills (corporate language)
Job Responsibility
Job Responsibility
  • Preparation of qualification and validation plans
  • Preparation and review of specifications, risk analyses, design documents, and project processes
  • Planning and execution of DQ, IQ, OQ, and PQ for production equipment
  • Preparation of qualification reports
  • Review of supplier documentation and coordination of supplier activities
  • GMP-compliant documentation of executed work
  • Handling of changes and deviations (Change Control & Deviations)
  • Preparation of Standard Operating Procedures (SOPs)
  • Maintenance and archiving of documentation
  • Ensuring training standards of project team members
  • Fulltime
Read More
Arrow Right

Thermal Validation & CQV Engineer

We are seeking an experienced Thermal Validation & CQV Engineer to lead and exec...
Location
Location
Canada , Toronto
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline
  • 3–6 years of CQV/CSV/thermal validation experience in a GMP pharmaceutical or biotech environment (Consultant/Intermediate level)
  • Strong hands-on experience with thermal cycle development, heat penetration studies, and BI logistics
  • Strong hands-on experience with temperature mapping and smoke studies
  • Strong hands-on experience with IOQ/PQ execution and requalification activities
  • Solid understanding of FAT/SAT, risk-based validation, FCCA, RTM, and CSV principles
  • Proficiency in Kaye AVS systems and familiar with Kneat and/or Veeva Vault
  • Strong knowledge of GMP/GLP/GDP/EHS and ALCOA+ data integrity standards
  • Excellent skills in technical writing, data/statistical analysis, and problem-solving
Job Responsibility
Job Responsibility
  • Lead and execute CQV activities for facilities, utilities, and process equipment across routine operations and capital projects
  • Author and review risk-based C&Q documentation: FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and thermal validation protocols
  • Plan and perform FAT/SAT, critical test plans, and CSV activities where applicable
  • Perform thermal validation using Kaye AVS v1.4+ (or equivalent)
  • Validate sterilization and decontamination systems
  • Support annual validation programs
  • Investigate and document deviations and non-conformances
  • Own documentation and scheduling
  • Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams
  • Promote continuous improvement and provide mentorship and guidance to junior validation staff
What we offer
What we offer
  • An international community bringing together more than 110 different nationalities
  • An environment where trust is central: 70% of our leaders started their careers at the entry level
  • A strong training system with our internal Academy and more than 250 modules available
  • A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)
Read More
Arrow Right

Engineering Manager – F&E Readiness

Amgen Dun Laoghaire (ADL) is developing a next-generation, technologically advan...
Location
Location
Ireland , Dun Laoghaire
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related discipline)
  • Experience (typically 5+ years) in engineering roles within a cGMP biopharmaceutical manufacturing environment
  • Experience in developing strategies for new product introduction and new technology deployment
  • Strong knowledge of, Equipment lifecycle management, Maintenance and reliability systems, GMP compliance, validation, and regulatory expectations
  • Proven ability to lead, build and develop teams, including working cross-functionally and managing complex stakeholder environments
  • Project management, problem-solving and decision-making capability
  • Excellent communication and technical writing skills
Job Responsibility
Job Responsibility
  • Act as the F&E representative within the capital project team, ensuring site requirements are embedded in facility and equipment design
  • Provide technical input and review of design deliverables (layouts, P&IDs, URS, specifications, automation strategies, maintenance concepts)
  • Ensure alignment with Amgen global standards, corporate blueprints and site operational requirements
  • Partner with Global Engineering, CQV, Automation, Quality and Operations to ensure a fully integrated and operable facility design
  • Identify and mitigate operability, maintainability and reliability risks early
  • Define and develop the F&E readiness strategy, including: Maintenance strategy and asset lifecycle plans
  • Spare parts and criticality assessments
  • Reliability and performance frameworks (OEE, predictive maintenance)
  • Establish systems to ensure equipment reliability and lifecycle ownership aligned with site expectations
  • Drive implementation of predictive and preventative maintenance philosophies from design through operation
What we offer
What we offer
  • competitive salary
  • comprehensive Total Rewards Plan including health, financial and career development benefits
Read More
Arrow Right
New

Associate Director Engineering – Global Capital Project Delivery

Amgen is seeking an Associate Director with experience in complex engineering, c...
Location
Location
Portugal , Lisbon
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master's degree in Engineering, Project Management, Procurement or related discipline
  • 10+ Years experience leading complex capital projects and / or project controls in a global organization
  • Strong understanding of supplier management, procurement interfaces, and project execution
  • Leadership and transformation experience. Ability to build new capabilities, operating models, or scalable business processes
  • Strong stakeholder management and influencing skills across global teams
  • A data-driven mindset with experience improving visibility, reporting, and decision-making
  • Experience in pharmaceutical, biotechnology, life sciences, advanced manufacturing, or other regulated industries preferred
Job Responsibility
Job Responsibility
  • Build and lead the Strategic Equipment Delivery workstream within Project Controls, including governance, stakeholder alignment, and scalable ways of working
  • Lead workstream to improve the predictability and visibility of end-to-end capital equipment delivery across Amgen's global project portfolio
  • Partner with engineering, procurement, sourcing, CQV, and project teams to drive integrated equipment planning and execution
  • Strengthen supplier engagement through improved milestone tracking, risk management, escalation processes, and delivery performance
  • Support early identification and mitigation of long-lead and business-critical equipment risks
  • Drive standardization, reporting, and data-driven decision-making to improve delivery performance and cost optimization
  • Collaborate with digital and analytics teams to enhance dashboards, reporting, and equipment delivery insights
  • Support supplier documentation readiness across the equipment lifecycle in partnership with cross-functional teams
What we offer
What we offer
  • Vast opportunities to learn, develop, and move up and across our global organization
  • Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
  • Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
  • Flexible work arrangements
  • Fulltime
Read More
Arrow Right

Clean Utilities & CIP Automation Coordinator

Piper Companies is seeking a Clean Utilities & CIP Automation Coordinator to sup...
Location
Location
United States , Holly Springs
Salary
Salary:
155000.00 - 175000.00 USD / Year
pipercompanies.com Logo
Piper Companies
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience supporting automation or controls within a cGMP pharmaceutical or biotech manufacturing environment
  • Hands-on experience with Emerson DeltaV DCS
  • familiarity with PLC-supported utilities systems (Siemens or Rockwell) is preferred
  • Strong understanding of automation change control, commissioning, and validation processes in FDA-regulated facilities
  • Working knowledge of Kneat validation software with the ability to review and support document generation
  • Proven ability to coordinate across technical and non-technical teams, communicate clearly under pressure, and manage shifting priorities on-site
Job Responsibility
Job Responsibility
  • Act as the primary on-site coordination point for clean utilities and CIP automation activities, aligning priorities across automation, utilities, CQV, and manufacturing teams
  • Drive automation deliverables through startup phases including commissioning, qualification, performance testing, and early engineering and production runs
  • Oversee system integrator execution for DeltaV-based utilities systems, ensuring software development, testing, and change execution align with operational needs
  • Review, contribute to, and approve lifecycle and validation documentation, including Kneat-based commissioning protocols, OQs, and automation change assessments
  • Communicate status, risks, and escalations effectively across cross-functional workstreams and participate in daily and tiered project meetings
What we offer
What we offer
  • Medical, Dental, Vision, sick leave if required by law, and 401K
  • Fulltime
Read More
Arrow Right

Vie Pharmaceuticals

We are offering international volunteer positions (VIE) for talented engineers a...
Location
Location
Belgium , Brussels
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master's degree in Chemical, Mechanical, Electrical, Automation, Environmental Engineering, or related field
  • Strong interest in the pharmaceutical, biotech, or life sciences industry
  • Basic understanding of GMP, validation, or industrial safety (training or internship experience accepted)
  • Technical aptitude and problem-solving mindset
  • Fluency in English and French or Dutch
  • Adaptability, teamwork, and willingness to work in a regulated environment
Job Responsibility
Job Responsibility
  • Support the execution of CQV protocols (IQ/OQ/PQ) for equipment, utilities, and processes
  • Assist in process validation (PPQ, CPV) and technical transfer activities
  • Collaborate with engineering and quality teams to ensure compliance with GMP and regulatory standards
  • Contribute to documentation (protocols, reports, change controls)
  • Provide technical support to manufacturing units to ensure operational efficiency
  • Investigate deviations, support CAPA implementation, and participate in internal audits
  • Ensure adherence to GMP, safety, and quality standards across production lines
  • Assist in continuous improvement projects (Lean, Six Sigma)
  • Implement and monitor EHS programs in line with local and international regulations
  • Conduct risk assessments, safety audits, and incident investigations
What we offer
What we offer
  • International experience under the VIE program
  • Monthly allowance
  • Health insurance
  • Travel coverage
  • Return ticket at the end of the mission
  • Mentorship and professional development within a global organization
  • Opportunity to work on high-impact projects in a cutting-edge pharmaceutical environment
  • Potential for future career opportunities within the group
Read More
Arrow Right