CrawlJobs Logo
PCI Pharma Services Logo PCI Pharma Services · Quality Control

Senior Validation Specialist

Ireland, Stamullen, Co. Meath · Job Posted February 20, 2026
Apply Position
Job Link Share

Job Description

The role of the Senior Validation Specialist is to implement and execute tasks relating to operational support for product launches, Process, Facility and Equipment Development at PCI Pharma Services sites.

Job Responsibility

  • Support the validation effort for all Strategic Projects on site
  • Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
  • Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
  • Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner
  • Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence
  • Support change controls as required
  • Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
  • Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
  • Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions
  • Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis
  • Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required

Requirements

  • Min 3 years' Quality experience
  • Min 2 years' Validation experience
  • Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
  • Process Validation (PV) experience
  • New Product Introduction (NPI) - Generation, execution and close out of validation projects
  • Communication Customer/Internal stake holders/Suppliers
  • Experience with deviation, CAPA processes
  • Flexible and able to manage multiple priorities simultaneously
  • Periodic reviews

Nice to have

  • Experience with packaging - secondary packaging / blister packaging and high speed / automated lines would be a distinctive advantage for this position
  • Ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to senior management
  • Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
  • Passion for Results: high energy, maturity, ability to work under pressure and deliver results
  • get things done (an action-oriented approach)
  • Cleaning Validation (CV)
  • Computer Systems Validation (CSV)
  • Temperature mapping
  • FAT, SAT
PCI Pharma Services - 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

Senior Validation Specialist

8 matching positions

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

Senior QC Specialist (Method Validation & Technical Support)

The Senior QC Specialist (Method Validation & Technical Support) is responsible ...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
amaris.com Logo
Amaris Consulting
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline
  • Minimum 5 years of experience in pharmaceutical or biopharmaceutical Quality Control, Analytical Development, or Technical Support functions within a GMP-regulated environment
  • Hands-on experience in analytical method validation, qualification, verification, transfer, equipment qualification (IQ/OQ/PQ), stability programs, and laboratory investigations (OOS/OOT, deviations, CAPAs, and change controls)
  • Strong knowledge of GMP requirements, analytical method lifecycle management, root cause analysis, GMP documentation, and global regulatory standards including FDA, USP, EP, ICH, PIC/S, and Data Integrity principles
Job Responsibility
Job Responsibility
  • Lead analytical method qualification, validation, verification, transfer, and lifecycle management for chemical and biological testing
  • Manage qualification of laboratory equipment, analytical instruments, and critical reagents, ensuring compliance throughout their lifecycle
  • Support introduction of new methods, technologies, materials, and equipment into QC operations
  • Coordinate and maintain QC stability programs, including data review and trend analysis
  • Lead investigations of deviations, non-conformances, invalid results, atypical results, and OOS events
  • perform root cause analysis and drive CAPA implementation
  • Monitor and implement regulatory and compendial updates to ensure ongoing compliance with GMP, FDA, USP, EP, and ICH requirements
  • Author, review, and approve GMP documentation including SOPs, protocols, reports, change controls, deviations, and CAPAs
  • Act as a technical SME, providing guidance, training, and knowledge transfer to QC testing teams
  • Support internal audits, regulatory inspections, and customer audits as the SME for assigned areas
  • Fulltime
Read More
Arrow Right

Senior Computer Systems Validation (CSV) Specialist

We are seeking a Senior Computer Systems Validation (CSV) Specialist to lead and...
Location
Location
United States , Charlton, MA or Goleta (Santa Barbara), CA
Salary
Salary:
92300.00 - 132300.00 USD / Year
karlstorz.com Logo
KARL STORZ
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 7+ years of CSV experience, including 5+ years in a regulated industry (medical device, aerospace, automotive, etc.)
  • Associate degree in Applied Science or equivalent experience/certifications
  • Strong knowledge of ISO 13485, FDA 21 CFR 820, and 21 CFR Part 11
  • Expertise in software validation standards, technical writing, and documentation control
  • Experience managing validation projects and collaborating across technical and business teams
  • Exceptional organizational, communication, and technical writing skills
  • Ability to manage multiple complex projects independently
  • Ability to travel up to 10%
Job Responsibility
Job Responsibility
  • Lead and manage the global CSV process for U.S. sites, partnering with cross‑functional and international teams
  • Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, and internal standards
  • Develop, review, and oversee validation lifecycle documentation, including plans, protocols, risk assessments, and reports
  • Analyze validation data, identify gaps, and support investigations and corrective actions
  • Manage vendors and consultants providing CSV services
  • Maintain validation tracking databases and contribute to process improvement initiatives
  • Represent CSV and IT during audits and regulatory inspections.
What we offer
What we offer
  • Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
  • 3 weeks vacation, 11 holidays plus paid sick time
  • Up to 8 weeks of 100% paid company parental leave
  • includes maternal/ paternal leave, adoption, and fostering of a child
  • 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • Tuition pre-imbursement up to $5,250 per year
  • Fitness reimbursement of up to $200 annually
  • Fulltime
Read More
Arrow Right

Bpo Configuration Analysis Senior Specialist

At NTT DATA, we know that with the right people on board, anything is possible. ...
Location
Location
India , Chennai
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Over all 5+ years’ experience in US healthcare Claims Payer
  • 6+ year(s) experience in Configuring client System for Pricing (Provider Contract) and UAT testing – 2+ Years
  • High school diploma or equivalent required
  • Ability to work within a project-oriented environment
Job Responsibility
Job Responsibility
  • Configuring client System for Pricing (Provider Contract) as per the requirement and according to defined business rules of new claims processing platform
  • Evaluation of Configuration Requirement and Formulation of Configuration Approach and Effectively include advanced configuration and additional functionality based on best practices
  • Based on the business requirements and business rules gathered, evaluate and create rules and complete the configuration activities
  • Participate in problem solving of Health Plan benefit, provider, pricing, reporting, operational and system issues
  • Perform a variety of tasks related to the resolution of production support issues based on client configurations with the core administrative system
  • Support activities to update configuration within the core claims processing system, typically within the areas of Provider Pricing
  • Support fee schedule changes including terms, affiliations and contract maintenance
  • Enable User Analysis Testing (UAT) and implement the modifications as suggested by the business owners and/or analyst
  • Creating manual test cases from Use cases, Functional specs and other requirement documents
  • Resolve coding/QA issues by managing Master Issue Logs and Fixing the high priority change requests which require immediate attention
Read More
Arrow Right
New

Configuration Analysis Senior Specialist

At NTT DATA, we know that with the right people on board, anything is possible. ...
Location
Location
India , Chennai
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Candidates must have Over all 5+ years’ experience in US healthcare Claims Payer
  • 6 + year(s) experience in Configuring client System for Pricing (Provider Contract) and UAT testing – 2+ Years
  • High school diploma or equivalent required, Technical/ Non-Technical
  • Associates degree, technical college or some college course work preferred
  • Ability to work within a project-oriented environment
  • Experience in SQL 2+ Years (Queries Writing)
  • Exposure on VB/Vb.net
Job Responsibility
Job Responsibility
  • Configuring client System for Pricing (Provider Contract) as per the requirement and according to defined business rules of new claims processing platform
  • Evaluation of Configuration Requirement and Formulation of Configuration Approach and Effectively include advanced configuration and additional functionality based on best practices
  • Based on the business requirements and business rules gathered, evaluate and create rules and complete the configuration activities
  • Participate in problem solving of Health Plan benefit, provider, pricing, reporting, operational and system issues
  • Perform a variety of tasks related to the resolution of production support issues based on client configurations with the core administrative system
  • Support activities to update configuration within the core claims processing system, typically within the areas of Provider Pricing
  • Support fee schedule changes including terms, affiliations and contract maintenance
  • Enable User Analysis Testing (UAT) and implement the modifications as suggested by the business owners and/or analyst
  • Creating manual test cases from Use cases, Functional specs and other requirement documents
  • Resolve coding/QA issues by managing Master Issue Logs and Fixing the high priority change requests which require immediate attention
  • Fulltime
Read More
Arrow Right
New

Senior Specialist - Technical Applications Group

The Senior Specialist, Technical Applications Group (TAG), serves as the product...
Location
Location
United States , Bridgewater
Salary
Salary:
95000.00 - 120000.00 USD / Year
nestlehealthscience.com Logo
Nestle Health Science
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Science, Food Science, or a related field
  • 3+ years of hands-on product development, formulation, and manufacturing experience involving tablets, capsules, liquids, soft gels, gummies, powders, packaging, or related technologies
  • Demonstrated knowledge of product development, technical and manufacturing processes, and food science principles
  • Experience leading medium-complexity technical projects and working effectively within cross-functional teams
  • Previous manufacturing or factory experience
  • Experience with product scale-up, validation, and technology transfer activities
  • Proficiency in Microsoft Office applications ( Excel, Word, PowerPoint, Outlook)
  • Preferred experience with SAP, SPSS (Statistical Package for the Social Sciences) and/or Minitab for data management, reporting, statistical analysis, and process improvement initiatives
  • Ability to be exposed to food allergens and allergen-containing materials
  • Knowledge of food safety, quality, and regulatory requirements
Job Responsibility
Job Responsibility
  • Lead product, process, and formulation development activities for innovation, renovation, optimization, and productivity projects
  • Provide technical expertise to support formulation improvements, process optimization, troubleshooting, and cost-saving initiatives
  • Lead scale-up, validation, and transfer of products and technologies to internal manufacturing sites and external partners
  • Conduct and oversee technical trials, risk assessments, and qualification activities to ensure successful commercialization and product performance
  • Anticipate and resolve manufacturing, formulation, and quality issues to maintain project timelines and product standards
  • Lead project execution, monitor progress, challenge assumptions when appropriate, and ensure achievement of project objectives and deadlines
  • Collaborate with Quality, Regulatory, Marketing, Procurement, Supply Chain, Manufacturing, and R&D teams to deliver project outcomes
  • Apply structured problem-solving methodologies to investigate and resolve technical and operational challenges
  • Support and maintain technical documentation, including master batch records, change controls, product specifications, QMS documentation, and related records
  • Mentor and coach junior team members while helping build technical capability across TAG and manufacturing teams
What we offer
What we offer
  • Performance-based incentives
  • 401k with company match
  • Healthcare coverage
  • Broad range of other benefits
  • Fulltime
Read More
Arrow Right
New

Bpo configuration analysis senior specialist

Join our team as a Senior BPO Configuration Analyst and play a key role in confi...
Location
Location
India , Chennai
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Candidates must have Over all 5+ years’ experience in US healthcare Claims Payer
  • 6 + year(s) experience in Configuring client System for Pricing (Provider Contract) and UAT testing – 2+ Years
  • High school diploma or equivalent required, Technical/ Non-Technical
  • Associates degree, technical college or some college course work preferred
  • Ability to work within a project-oriented environment
  • Experience in SQL 2+ Years (Queries Writing)
  • Exposure on VB/Vb.net
Job Responsibility
Job Responsibility
  • Configuring client System for Pricing (Provider Contract) as per the requirement and according to defined business rules of new claims processing platform
  • Evaluation of Configuration Requirement and Formulation of Configuration Approach and Effectively include advanced configuration and additional functionality based on best practices
  • Based on the business requirements and business rules gathered, evaluate and create rules and complete the configuration activities
  • Participate in problem solving of Health Plan benefit, provider, pricing, reporting, operational and system issues
  • Perform a variety of tasks related to the resolution of production support issues based on client configurations with the core administrative system
  • Support activities to update configuration within the core claims processing system, typically within the areas of Provider Pricing
  • Support fee schedule changes including terms, affiliations and contract maintenance
  • Enable User Analysis Testing (UAT) and implement the modifications as suggested by the business owners and/or analyst
  • Creating manual test cases from Use cases, Functional specs and other requirement documents
  • Resolve coding/QA issues by managing Master Issue Logs and Fixing the high priority change requests which require immediate attention
  • Fulltime
Read More
Arrow Right
New

Trade Compliance Senior Specialist

We are seeking a detail-oriented Trade Compliance Specialist to ensure complianc...
Location
Location
Hungary , Budapest
Salary
Salary:
Not provided
vodafone.com Logo
Vodafone
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3–5 years’ relevant investigative experience in compliance or risk management
  • Strong understanding of export control and sanctions regulatory frameworks (e.g. OFAC, EU, UN)
  • Demonstratable experience in conducting extensive due diligence on complicated organisational structures to identify accurate ownership and control information
  • Competence in interpreting legal provisions, reviewing sanctions listings, and evaluating transactional risks
  • Strong analytical and problem-solving capabilities
  • Able to collaborate effectively with diverse stakeholders
  • Detail-focused, with a structured and methodical approach to work
  • Fluent English
Job Responsibility
Job Responsibility
  • Review escalations from first-line screening, assessing data accuracy, transactional details, and contextual factors to determine outcomes
  • Conduct thorough due diligence on entities, including ownership and control structures, and create accurate organisational mappings
  • Engage with internal stakeholders to gather and validate necessary information
  • Analyse applicable regulatory restrictions, including sanctions and export control frameworks
  • Determine potential business impacts and recommend compliant courses of action
  • Escalate confirmed cases to relevant decision-makers for final resolution
  • Document all assessments, findings, and decisions clearly and accurately
  • Provide oversight and quality assurance of first-line compliance activities
  • Collaborate with internal teams to ensure timely resolution of flagged cases
  • Stay informed about changes to global sanctions and export control regimes (e.g., OFAC, EU, UN)
What we offer
What we offer
  • Opportunity to work in a global compliance environment with cross-functional exposure
  • Involvement in complex, high-impact regulatory decision-making
  • A collaborative and supportive team culture
  • Continuous learning through exposure to international trade compliance frameworks
  • Career development within a large, global organisation
  • A dynamic and collaborative work environment that fosters innovation and continuous improvement
  • The chance to influence customer experience and product optimisation at scale
  • A dynamic environment where innovative ideas are always welcome
  • A collaborative community where your professional goals and work are supported by a diverse team
  • Access to internal and external trainings via other providers
  • Fulltime
Read More
Arrow Right