Commissioning and Qualification Engineer

7 days ago

Kalamazoo, Michigan, United States Verista Full time
Job Description

At Verista, we empower growth and innovation within the scientific community by providing innovative solutions and services that enable informed decision-making. Our team of experts works with the world's most recognizable brands in the life science industry to solve their business needs.

We are seeking a highly skilled Senior Validation Engineer to join our team. As a key member of our team, you will be responsible for managing and working collaboratively with clients' quality representatives to complete deviation investigations and resolutions for problems and issues encountered during execution activities.

Key Responsibilities:

  • Managing and working collaboratively with clients' quality representatives to complete deviation investigations and resolutions.
  • Supporting clients' change management programs, including authoring proposed changes, executing impact assessments, and supporting client documentation of change results and release.
  • Authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment, systems, and software.
  • Running test scripts and documenting results.
  • Adhering to project schedules 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 alarm testing on automated systems.
  • Developing, reviewing, and executing testing documentation.
  • Making recommendations for design or process modification based on test results.
  • Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
  • General understanding of capital equipment implementation and process knowledge.
  • Understanding validation documents, URS, IQ, OQ, PQ.
  • Verifying system drawings, including reviewing and as-built P&IDs and I&C drawings, as well as verifying electrical schematics with support of an electrical engineer.

Requirements:

  • Bachelor of Science in a technical field (engineering, life science, or equivalent) from an accredited institution.
  • Minimum 4 years of technical experience.
  • Experience in a pharmaceutical/FDA-regulated manufacturing environment, with 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/systems (e.g., PLC-controlled).
  • 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.

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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