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Lead Validation Engineer in Biopharmaceuticals
2 months ago
GxPeople Global is collaborating with a prominent entity in the biopharmaceutical industry to present an exceptional opportunity for a proficient Senior Validation Specialist with a robust background in QC laboratory Computer Systems and Instruments.
Key Responsibilities:
- Conducts validation activities for QC analytical instruments and software, which includes drafting GMP procedures, validation documentation, and executing testing protocols.
- Acts as a team leader, responsible for drafting, reviewing, and approving project plans related to QC analytical instrument and software validation.
- Independently manages projects to ensure they are completed on schedule.
- Oversees software administration tasks, such as converting test methodologies, batch records, and other documentation into instrument computer system software.
- Performs user and application software administration on Enterprise systems, which includes reviewing system audit trails, monitoring backups, and maintaining validation on systems.
- Suggests and implements engineering controls for analytical instruments and software utilized in QC Laboratories. May serve as a Subject Matter Expert during regulatory inspections and audits.
- Oversees all facets of Quality Management System processes, including Change Control, Deviations, CAPAs, and Tasks. Responsible for writing, reviewing, assessing, and/or approving change controls for analytical instruments and software used in QC laboratories and manufacturing.
- Ensures compliance with company SOPs and specifications, as well as FDA and cGMP regulations, while maintaining data integrity.
- Identifies and addresses compliance deficiencies as necessary.
- Performs additional duties as assigned.
Key Requirements:
- Bachelor's Degree is required, preferably in Microbiology, Biochemistry, Chemistry, Engineering, Computer Science, or related scientific disciplines.
- A minimum of 5-7 years of experience in the validation of Analytical Laboratory Computer Systems and Instruments.
- At least 5 years of experience managing local systems, preferably TOC and Softmax.
- Demonstrated proficiency in problem-solving and critical thinking.
- Strong knowledge of regulatory standards.
- Experience in data integrity and the Software Development Life Cycle (SDLC).
- Experience in a Quality Control Laboratory or with enterprise computer systems, as well as GMP Quality Systems such as TrackWise, LIMS, LES, Empower, and MODA.
- Prior experience in project management.
Note: This position is exclusively available to candidates possessing a valid US working visa.
