Senior Validation Expert
1 day ago
Verista, a leading provider of life science solutions, seeks an experienced Validation Expert to join our team in New Brunswick, NJ. As a key member of our quality assurance team, you will play a crucial role in ensuring the compliance and regulatory requirements of our clients are met.
The ideal candidate will have extensive experience in validating production equipment in pharmaceutical environments and possess expertise in isolators, bioreactors, fume hoods, and other lab equipment. Strong knowledge of regulatory requirements and risk-based validation approaches is essential for this position.
Responsibilities- Authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment/systems/software and processes as part of a team directed by the project leader.
- Running test scripts and documenting results.
- Adherence with project schedule for all assigned activities.
- Maintaining clear, detailed records of qualification and validation.
- Documenting impact and risk assessments as part of a team.
- Completing user interface testing, software verification, and complete alarm testing on automated systems.
- Developing, reviewing, and executing testing documentation.
- Making recommendations for design or process modification based on test results when executing test scripts.
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ.
- Leading CQV efforts for facilities and utilities, including HVAC, water systems, and building automation.
- Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems.
- Collaborate with engineering and project teams to align validation activities with construction schedules.
- Ensure all validation documentation complies with regulatory standards (FDA, cGMP).
- Bachelor's degree in Engineering, Life Sciences, or related field.
- 10+ years of experience in validating production equipment in pharmaceutical environments.
- Expertise in isolators, bioreactors, fume hoods, and other lab equipment.
- Strong knowledge of regulatory requirements and risk-based validation approaches.
- Excellent project management and problem-solving skills.
- Excellent documentation and communication skills.
- Demonstrated experience in leading CQV activities specific to expertise in Facility and Utility qualification.
- Experience in qualifying "first in kind" equipment.
- Experience with Robotic arms and processing.
- Proficiency using PC and Microsoft Office tools.
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
- Ability to work as part of a team.
- Strong problem-solving and critical thinking skills.
- Excellent organizational and time management skills.
- Strong attention to detail.
- GMP and Good Documentation Practice.
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
- Basic skills with EXCEL and PowerPoint.
- Strong interpersonal skills and clear communication capabilities.
- Experience with and tolerance for high levels of challenge and change.
- Experience in GMP regulated environment.
- Proven attention to detail and organization in project work.
- Capable of working on assigned tasks without mentorship.
We offer a competitive salary range of $80,465 - $129,826, depending on experience and qualifications. In addition to a comprehensive benefits package, including medical, dental, and vision insurance, we also provide 401(k) retirement plan, paid time off, holidays, and tuition reimbursement opportunities.
We are an equal opportunity employer and encourage applications from qualified candidates. Please note that the salary range may be modified in the future.
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