GxP Validation Engineer/Analyst (Lab Equipment)

Begell House Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

Job summary

White Collar Technologies is seeking a Validation Specialist to support QC instrumentation validation and CGMP maintenance. The role includes authoring CAPAs, remediation SOPs, and driving validation deliverables across multi-disciplinary teams.

Qualifications include a biotech/pharma background with Instrument or CSV validation experience and a Bachelor's degree in engineering, life sciences, or computer science. Knowledge of GAMP and CFR Part 11 is essential.

Qualifications

• Validation experience in biotech/pharmaceutical environments, specializing in Instrument or Computer System Validation.
• Excellent working knowledge of process automation and CSV concepts, CFR Part 11 Electronic Records and Signatures, data integrity expectations.

Responsibilities

• Provide validation support for QC Instrumentation hardware/software to maintain CGMP status.
• Author and maintain Validation Plans and CAPAs; drive remediation activities and SOP revisions.
• Lead deviations resolution during protocols and approve vendor documentation.
• Develop and execute deliverables such as Risk Assessments, Validation Plans, IQ/OQ/PQ protocols and Summary Reports.

Skills

Validation expertise

GxP compliance

Mentoring

Education

Bachelor's degree in engineering/life sciences/computer science

Tools

GAMP

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.