AT02-032426 Validation Specialist
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Job Location:
Duluth, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.
Summary:
We are seeking a Validation Specialist to support product transfer and validation activities within a regulated manufacturing environment at a client site in Johns Creek GA.
This role will focus on equipment qualification and technical documentation (IOQ/PQ) supporting ongoing manufacturing transfer projects where timelines coordination and execution readiness are critical. The selected candidate must be proactive detail-oriented and capable of managing multiple deliverables across parallel workstreams.
Responsibilities:
- Develop review and execute validation documentation including:
- Risk assessments
- Commissioning and qualification protocols (IOQ IQ/OQ/PQ)
- Summary reports
- Support product transfer activities ensuring validation deliverables align with project milestones and manufacturing readiness.
- Coordinate closely with stakeholders to support the protocol approval process addressing comments and driving timely closure.
- Prepare for and support execution activities including:
- Verification of prerequisites
- Staging of documentation and supporting evidence
- Ensuring readiness for IOQ/PQ execution
- Support equipment utilities and facilities qualification activities.
- Support deviations investigations and documentation updates during execution.
- Collaborate with engineering quality manufacturing and project teams to support aggressive project timelines and multiple concurrent initiatives.
- Ensure all validation deliverables comply with cGMP requirements FDA regulations and site procedures.
Qualifications:
- Bachelors degree in Engineering or a related scientific discipline preferred.
- Minimum 4 years of experience supporting CQV or validation activities in a GMP-regulated environment.
- Strong experience in technical writing and protocol development (IOQ/PQ focus).
- Experience supporting equipment qualification within product transfer or manufacturing change environments strongly preferred.
- Kneat experience required.
- Experience in the medical device industry preferred; experience in contact lens manufacturing is highly preferred.
- Strong understanding of cGMP and regulatory expectations.
- Ability to work on-site in a fast-paced deadline-driven environment.
- Strong organizational communication and problem-solving skills.
- Willingness and ability to travel as needed for future project assignments.
At Validation & Engineering Group people always come first. We believe that when youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven supportive team.
Excited to build something meaningful together We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status.
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Required Experience:
IC
Key Skills
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
