6461 - Senior CQV Engineer / Senior Validation Engineer
About The Position
Verista is hiring a Senior CQV Engineer / Senior Validation Engineer to support life sciences clients, including pharmaceutical manufacturing operations. The role involves planning, authoring, executing, and documenting commissioning, qualification, and validation activities for equipment, systems, software, and processes. The position is based onsite in the Indianapolis metropolitan area, with willingness to meet potential future travel requirements of 10–50%. The successful candidate will have 4–6 years of relevant experience, including leading CQV activities in pharmaceutical manufacturing, and will be able to work independently while guiding less experienced team members and communicating effectively with clients and project teams.
Requirements
- Bachelor’s degree or equivalent.
- 4–6 years of demonstrated role-relevant experience.
- Demonstrated experience leading CQV activities specific to pharmaceutical manufacturing requirements.
- Must be able and willing to work onsite in the Indianapolis metropolitan area.
- Must be willing to meet potential future travel requirements of 10–50%.
- Ability to communicate effectively with clients and collaborate with different levels of a client organization, explaining requirements and rationale in writing and orally.
- Ability to work independently on assigned tasks without mentorship and as part of a team.
- Proficiency with PCs and Microsoft Office tools.
- Intermediate Microsoft Word skills, including authoring and editing large technical documents using styles, tables, tables of contents, and track changes.
- Basic Microsoft Excel and PowerPoint skills.
- Knowledge of GMP and Good Documentation Practice, and experience in a GMP-regulated environment.
- Strong problem-solving and critical-thinking skills.
- Excellent organizational and time-management skills, attention to detail, and organization in project work.
- Strong interpersonal and communication skills, including clear, concise communication with peers.
- Experience with and tolerance for high levels of challenge and change.
- Outgoing, business-mature, and collaborative demeanor.
Responsibilities
- Design validation plans.
- Conduct and document impact and risk assessments, understanding equipment, system, and software operation and assessing direct, indirect, and no-impact systems and functions within complex processes.
- Maintain clear, detailed qualification, validation, and change-control records to support future compliance audits, and ensure the team does so as well.
- Design and execute engineering studies to define and verify critical process parameters before validation.
- Author, edit, and execute technical commissioning, qualification, and validation documentation for standard equipment, systems, software, and processes as directed by the project leader.
- Run test scripts and document results.
- Adhere to project schedules for assigned activities.
- Complete user interface testing, software verification, and alarm testing on automated systems.
- Develop, review, and execute testing documentation.
- Recommend design or process modifications based on test-script results.
- Apply a general understanding of capital equipment implementation and process knowledge.
- Understand validation documents, including URS, IQ, OQ, and PQ.
- Mentor and guide less experienced team members.
- Identify potential areas of business expansion and report them to the management team for follow-up.
Benefits
- Competitive pay plus performance-based incentive programs.
- Company-paid life, short-term disability, and long-term disability insurance.
- Medical, dental, and vision insurance.
- FSA, DCARE, and commuter benefits.
- Supplemental life, hospital, critical illness, and legal insurance.
- Health Savings Account.
- 401(k) retirement plan with employer matching.
- Paid time off with 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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What This Job Offers
Job Type
Full-time
Career Level
Senior
