Validation Engineer Senior
Posted: 06/16/2026
Job Number: 42428
Job Description
Validation Engineer Senior
Onsite
Summary
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities.
Responsibilities
Pay range is $60 - $65 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
Onsite
Summary
Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities.
Responsibilities
- Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
- Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
- Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified GMP analytical and process equipment, utilities, and facilities.
- Execute IQ, OQ, FT, PQ protocols, which may involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP analytical and process equipment, utilities, and facilities.
- Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
- Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
- Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems in collaboration with both internal and external partners.
- May include conducting validation maintenance activities including performing and scheduling periodic reviews.
- Other duties may be assigned to this role.
- Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
- Knowledge of cGMP commissioning/qualification/validation practices.
- Familiarity with Kneat Gx Platform or other digital C&Q systems.
- Experience working with cross-functional stakeholders.
- Knowledge of quality assurance principles.
- Experience working within project teams and multiple projects in parallel.
- Effective communication skills, both verbal and written.
- Able to think analytically with the ability to resolve issues.
- Able to manage own time efficiently.
- Doctorate degree
- Masters degree and 2 years of experience
- Bachelors degree and 4 years of experience
- Associates degree and 8 years of experience
- High school diploma / GED and 10 years of experience
Pay range is $60 - $65 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
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