Title : Validation Engineer
Location: Portsmouth, NH (100% Onsite)
Duration: 6-Month Contract (Potential Extension)
Schedule: Normal business hours
Pay Range: $71 to $75/Hr.
Job Description:
Job Summary:
We are seeking a QA Validation Specialist III to support equipment validation and cleaning validation activities within a GMP biopharmaceutical manufacturing environment. The ideal candidate will have hands-on experience with Kneat, equipment qualification, validation lifecycle documentation, and GMP quality systems.
Key Responsibilities:
- Execute equipment validation activities, including IQ, OQ, PQ, and equipment requalification.
- Develop and maintain validation protocols, reports, and supporting documentation using Kneat.
- Support cleaning validation activities, including CIP, COP, SIP, Media Hold, and Media Fill processes.
- Perform validation for manufacturing equipment such as Autoclaves, Parts Washers, Controlled Storage Equipment, and Single-Use Systems.
- Conduct temperature mapping activities (experience with Ellab is a plus).
- Review and support SOPs, validation protocols, change controls, deviations, and CAPAs.
- Maintain equipment in a validated state through validation maintenance and periodic requalification.
- Support qualification of clean utilities and controlled environments.
- Collaborate with Manufacturing, Quality Control, Engineering, and Quality Assurance teams to execute validation activities.
- Perform Quality Systems activities within TrackWise and Document Management Systems (DMS).
Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related discipline.
- Experience in Equipment Validation within a GMP pharmaceutical or biopharmaceutical environment.
- Hands-on experience with Kneat (Required).
- Strong understanding of IQ/OQ/PQ, equipment qualification, and validation lifecycle.
- Experience with Cleaning Validation (CIP, COP, SIP).
- Knowledge of GMP documentation, validation protocols, and SOP development.
Preferred Qualifications:
- Experience with Ellab temperature mapping.
- Experience validating Autoclaves, Parts Washers, Controlled Storage Equipment, or Single-Use Systems.
- Experience with TrackWise, Change Controls, Deviations, and CAPA.
- Knowledge of clean utilities and controlled environments.
- Preferred BackgroundCandidates with experience supporting validation activities in pharmaceutical, biopharmaceutical, biotechnology, or GMP-regulated manufacturing environments are strongly encouraged to apply.
About Mindlance:
Founded in 1999, Mindlance has been ranked as one of the fastest growing US Staffing firms by SIA for 9 consecutive years. We provide workforce solutions to Global 1000 companies in Technology, Engineering, Finance, Clinical Research, Scientific, Digital/Creative/Marketing space.
Mindful of the opportunity gap, we provide balanced solutions for both employers and job seekers—elevating the standards of recruitment practice to a whole new level. Our aim is to make a difference in the lives of job seekers by providing them with opportunities that broaden career horizons and expand skill sets. We take pride in being a strong driver of mindfulness and balance at workplace.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Pay: $71.00 - $75.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Referral program
- Vision insurance
Work Location: In person
