Validation Contractor, Quality Assurance

Position Title:

Validation Contractor, Quality Assurance

Work Location:

Westborough, MA 01581 Assignment Duration: 06 Months Work Arrangement:
Onsite

Position Summary:

The Validation Contractor, Quality Assurance, will provide validation support to the organization's cGMP Cell Therapy Manufacturing facility as the products move through clinical trials and commercialization. This role ensures that all systems comply with applicable regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, and that validation deliverables are developed in alignment with corporate and industry best practices.

Background & Context:
The successful candidate will foster compliance across Manufacturing, Quality Control, Cytogenomics and Materials Management teams to ensure high quality standards and value delivery for our patients.

• Individual Contributor responsible for executing Validation Strategy for clinical and pre-commercial cell therapy manufacturing facility.
• Responsible for equipment, computerized systems, and facility validation.
• Supports Data Integrity initiatives and periodic reviews.
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable company policies and SOPs.
• Authors technical documents such as User Requirement Specifications (URS), Regulatory Assessment and System Categorization (RASC), Functional Specification (FS), Configuration Specification (CS), Traceability Matrix (TM), deviations, and risk assessments.
• Writes, executes and reviews validation protocols (IOPQ) and reports following good documentation practices.
• Interface with business process owners, system owners, IT and facilities engineering to ensure all user and compliance requirements are tested.
• Evaluate vendor qualification packages and create supplemental protocols as necessary.
• Reviews executed protocols for controlled temperature units and lab instrumentation.
• Maintains close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation and the validated state of equipment.
• Collaborates with cross-functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.), assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.

• Experience supporting biologics, cell therapy and/or gene therapy in a GxP environment.
• Demonstrated knowledge of GAMP 5 principles and 21
  
  CFRpart
  11/EU Annex 11 regulations.
• Experience with creating and reviewing validation lifecycle documentation for laboratory benchtop instruments with computerized systems.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.
• Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
• Working fluency in the Microsoft Office productivity suite (including Excel to include basic formulas, and creation / formatting of charts and data tables).
• Solid technical writing skills with ability to document work in a meticulous and accurate manner.
• Proven ability to manage multiple projects and priorities in a fast-paced, regulated environment.

• BS/BA, or equivalent, in Life Sciences, Engineering, or Chemistry with 1-3+ years of related validation experience within GMP-regulated industry. In lieu of a Life Sciences, or equivalent, degree, consideration will be given to candidates with minimum of 5+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
• Experience with an electronic document management system
• Experience with data acquisition software, such as KAYE Validator and Ellab Val Suite data loggers used to perform mapping studies.

• This position is based in Westborough, MA and will require on-site work.
• This position may require occasional work in a cleanroom environment.