GxP Validation Engineer/Analyst (Lab Equipment)

ZipRecruiter; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a Validation Specialist to support QC Instrumentation and maintain compliance with CGMP standards. The successful candidate will lead validation activities, author documentation, and mentor junior team members in a dynamic environment.

Qualifications

• Experience in biotech/pharmaceutical validation.
• Knowledge of GAMP methodologies and CFR Part 11.
• Ability to work in a fast-paced environment.

Responsibilities

• Support QC Analytical department activities for CGMP compliance.
• Author and manage Corrective & Preventive Action plans.
• Develop validation deliverables like Risk Assessments and Validation Plans.

Skills

Validation experience

Process automation

GxP compliance

Mentorship

Education

Bachelor's Degree in Engineering, Life Science, or Computer Science

Job description

Responsibilities:

• Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software, and perform comparability studies for the implementation of analytical assays on new instrumentation. This includes QC Instruments (both portable and computer-controlled).
• Author Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and final reports for systems with short-term/completed remediation.
• Support remediation work such as SOP revisions.
• Execute change controls and validation test plans/protocols as required per remediation plans.
• Develop and execute deliverables like Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specifications, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.

Desired Skills and Experience:

• Author, maintain, revise, and approve Validation Plans.
• Lead resolution of deviations during protocol execution.
• Manage and approve vendor documentation as appropriate.
• Influence and impact validation and GxP compliance across teams.
• Ability to work in a fast-paced, dynamic small company environment.
• Mentor junior team members.
• Experience in other validation areas such as CSV qualification, Facility Equipment, and Utility validation is a plus.

Required Qualifications:

• Validation experience in a biotech/pharmaceutical environment, focusing on Instrument or Computer System Validation.
• Bachelor's Degree in Engineering, Life Science, or Computer Science.
• Strong knowledge of process automation, computer system validation concepts, GAMP methodologies, CFR Part 11, electronic records and signatures, and data integrity standards.