GxP Validation Engineer/Analyst (Lab Equipment)

WHITE COLLAR TECHNOLOGIES INC; Cambridge (MA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision benefits

Job summary

White Collar Technologies seeks a Validation Specialist to support QC Analytical such that CGMP status is maintained for instrumentation hardware and software. You will drive remediation initiatives, author CAPAs and final reports, and revise SOPs as needed.

The role requires hands-on validation expertise in biotech/pharma environments, plus CFR Part 11 and data integrity knowledge. This fast-moving, small company offers a collaborative atmosphere and opportunities to mentor others.

Qualifications

• Validation experience in biotech/pharma environments.
• GxP compliance and data integrity knowledge.
• Understanding of CFR Part 11 Electronic Records and Signatures.

Responsibilities

• Support QC Analytical for CGMP status of instrumentation hardware/software.
• Author CAPAs and final reports for remediation activities.
• Revise SOPs related to remediation work.
• Execute change controls and validation test plans per remediation plans.
• Develop and execute validation-related deliverables and reports.

Skills

Validation in biotech/pharma

GxP compliance

CFR Part 11 knowledge

Education

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

Job description

Job Description

Job Description

Responsibilities

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

Desired Skills and Experience

• Author, maintain, revise, and/or approve of the Validation Plan.
• Lead the resolution of deviations noted during protocol execution.
• Manage and approve vendor's documentation as appropriate.
• Ability to impact and influence people/areas in matters related to Validation and GxP compliance.
• Ability to work in a fast-moving dynamic small company environment.
• Ability to mentor junior team members.
• Experiences in other validation areas which may include CSV qualification and Facility Equipment and Utility is a plus.

Required Qualifications

• Validation experience in a biotech/pharmaceutical environment, specializing in Instrument or Computer System Validation
• Bachelor's Degree in Engineering, Life Science or Computer Science is required.
• Excellent working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.

Company Description

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.

• We offer our workers Medical Dental and Vision healthcare benefits.

Company Description

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.

• We offer our workers Medical Dental and Vision healthcare benefits.