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Lead CQV Specialist

2 months ago

Kalamazoo, Michigan, United States Verista Full time
About Verista: Verista is a leading organization comprised of 600 experts collaborating with some of the most renowned brands in the life sciences sector to address their operational needs. Our mission is to foster growth and innovation within the scientific community, assisting researchers, organizations, and companies in tackling significant healthcare challenges. We offer cutting-edge solutions and services that facilitate informed decision-making, stemming from our substantial investment in our workforce and capabilities.

Company Culture & Values:
  • We empower and support our colleagues.
  • We are dedicated to client success at every opportunity.
  • We possess the courage to act ethically.
  • We promote an inclusive environment where our colleagues feel valued, engaged, and challenged.
  • We continually enhance our skills and learn from our experiences to improve our collective expertise.
Key Responsibilities of the CQV Engineer:
  • Collaborate with clients' quality representatives to conduct deviation investigations and resolve issues encountered during execution activities, including performing root cause analysis.
  • Support clients' change management initiatives by authoring proposed changes, executing impact assessments, and assisting in the documentation of change results.
  • Draft, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment, systems, software, and processes as directed by the project leader.
  • Execute test scripts and meticulously document results.
  • Ensure adherence to project schedules for all assigned tasks.
  • Maintain comprehensive and detailed records of qualification and validation activities.
  • Document impact and risk assessments as part of a collaborative team.
  • Conduct user interface testing, software verification, and comprehensive alarm testing on automated systems.
  • Develop, review, and execute testing documentation.
  • Provide recommendations for design or process modifications based on test outcomes.
  • Interpret technical schematics to identify, locate, and test photo sensors, verify part numbers, and perform I/O testing on automated manufacturing equipment.
  • Possess a general understanding of capital equipment implementation and process knowledge.
  • Comprehend validation documents, including URS, IQ, OQ, and PQ.
  • Verify system drawings, including reviewing as-built P&IDs and I&C drawings, and validating electrical schematics with the support of an electrical engineer.
Qualifications:
  • Willingness to work onsite.
  • Bachelor's degree in a technical field (engineering, life sciences, or equivalent) from an accredited institution.
  • A minimum of 4 years of technical experience.
  • Experience in a pharmaceutical or FDA-regulated manufacturing environment, with a solid understanding of cGMP and facility/equipment validation requirements.
  • Excellent oral and written communication skills, including the ability to present effectively.
  • Proficient in writing clearly, concisely, and persuasively in a professional context.
  • Ability to interact effectively with all organizational levels.
  • Understanding of a risk-based approach to commissioning and qualification.
  • Experience with testing automated manufacturing equipment/systems.
  • Strong interpersonal skills and effective communication abilities.
  • Proficient problem-solving and critical thinking skills.
  • Exceptional organizational and time management capabilities.
  • Attention to detail.
  • Familiarity with GMP and Good Documentation Practices.
  • Intermediate skills in WORD for authoring and editing large technical documents.
  • Basic skills in EXCEL and PowerPoint.
  • Experience in a GMP-regulated environment.
  • Proven organizational skills in project work.
  • Ability to work independently on assigned tasks.
Why Choose Verista?
  • High growth potential in a fast-paced, people-focused organization.
  • Competitive compensation with performance-based incentives.
  • Comprehensive insurance coverage, including life, short-term, and long-term disability.
  • Medical, dental, and vision insurance options.
  • Flexible spending accounts and commuter benefits.
  • 401(k) retirement plan with employer matching.
  • Generous paid time off and holiday policies.
  • Tuition reimbursement programs.
  • Employee recognition and referral programs.
  • Paid parental leave and bereavement support.