GxPeople are working with a major player in the biopharmaceutical sector on an exciting opportunity for a skilled Lead Validation Engineer with experience working with QC laboratory Computer Systems and Instruments.

Senior Lead QC System Validation

Key Responsibilities:

Completes QC analytical instrument and software validation tasks, including writing GMP procedures, validation documents, and executing test scripts.
Serves as a leader for the team, drafting, reviewing, and approving QC analytical instrument and software validation project plans.
Manages projects independently to ensure timely completion.
Handles software administration duties, including converting test methods, batch records, and other written documents into instrument computer system software.
Performs user and application software administration on Enterprise systems, including system audit trail reviews, monitoring backups, and performing validation maintenance on systems.
Recommends and implements engineering controls for analytical instruments and software in QC Laboratories. May act as an ACSV SME during regulatory and customer inspections and audits.
Manages all aspects of QMS processes, including Change Control, Deviations, CAPAs, and Tasks. Writes, reviews, assesses, and/or approves change controls for analytical instruments and software used in QC laboratories and manufacturing.
Ensures data integrity and compliance with company SOPs and specifications, FDA, and cGMP regulations.
Identifies and addresses compliance gaps as needed.
Performs other duties as assigned.

Key Requirements:

Bachelor’s Degree required, preferably in Microbiology, Biochemistry, Chemistry, Engineering, Computer Science, or related science fields.
Minimum of 5-7 years of experience in Analytical Laboratory Computer Systems and Instrument Validation.
At least 5 years of experience administering local systems, preferrably TOC and Softmax.
Proficient in problem-solving and critical thinking.
Strong understanding of regulatory requirements.
Experience in data integrity and SDLC life cycle.
Experience working in a Quality Control Laboratory or with enterprise computer systems, and GMP Quality Systems such as TrackWise, LIMS, LES, Empower, and MODA.
Previous project management experience.

*This role is only open to candidates with a current US working visa*

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