Senior Validation Specialist

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*