Associate Validation Specialist

1 week ago

Kalamazoo, Michigan, United States Verista Full time
Job Overview

Verista, a leading provider of innovative solutions and services to the life science industry, is seeking a highly skilled and motivated Associate Validation Engineer to join our team. As a key member of our commissioning and verification team, you will play a critical role in ensuring the quality and integrity of our clients' products.

Key Responsibilities
  • Draft and Execute Verification Testing Protocols
  • Collaborate with cross-functional teams to establish priorities and define commissioning and verification requirements for assigned workstreams.
  • Review technical specification documents, drawings, and vendor design submittals to ensure compliance with Good Manufacturing Practice (GMP) and project requirements.
  • Lead and participate in the development and execution of complete verification documentation in accordance with Pfizer Quality Standards and cGMP requirements.
  • Collaborate with other workstream leads to ensure effective integrated verification strategy of integrated systems and equipment.
  • Provide or arrange for the development of complete verification documentation in accordance with Pfizer Quality Standards and cGMP requirements.
  • Maintain a working familiarity with current industry best practices and cGMP requirements.
  • Assist the C&V Lead with the preparation of C&V status reports.
Requirements
  • Bachelor of Science in a technical field (engineering, life science, or equivalent) from an accredited institution.
  • 1-3 years of technical experience in a pharmaceutical or FDA-regulated manufacturing environment.
  • Experience in a GMP-regulated environment and a solid working knowledge of cGMP and facility/equipment validation requirements.
  • Excellent oral and written communication skills, including presentations.
  • Ability to write clearly, concisely, and persuasively in a professional environment.
  • Demonstrated ability to interact effectively with all levels of the organization.
  • Demonstrated understanding of risk-based approach to commissioning and qualification.
  • Experience with testing of automated manufacturing equipment or systems.
  • 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 a GMP-regulated environment.
  • Proven attention to detail and organization in project work.
  • Capable of working on assigned tasks without mentorship.
Benefits
  • High growth potential and fast-paced organization with a people-focused culture.
  • Competitive pay plus performance-based incentive programs.
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances.
  • FSA, DCARE, Commuter Benefits.
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance.
  • Health Savings Account.
  • 401(k) Retirement Plan (Employer Matching benefit).
  • Paid Time Off (Rollover Option) and Holidays.
  • As Needed Sick Time.
  • Tuition Reimbursement.
  • Team Social Activities.
  • Employee Recognition.
  • Employee Referral Program.
  • Paid Parental Leave and Bereavement.

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