Validation Engineer-Belvedere
Job Description
- Develop and execute DQ/IQ/OQ/PQ validation protocols in compliance with cGMP standards
- Support FAT and SAT commissioning & qualification activities with customers
- Create and maintain technical documentation including:
- Functional Design Specifications
- Software & Hardware Design Specs
- Configuration & Vision Specs
- Technical Manuals & Operator Guides
- Machine Instructions & Spare Parts Documentation
- Execute machine test cases to verify functionality and quality performance
- Update validation documentation in Kneat Gx
- Conduct risk assessments and FMEA activities
- Support CE technical construction file development
- 2-year technical degree in engineering or related field
- 3+ years of experience writing technical documentation in manufacturing environments
- Experience with validation protocols and commissioning activities
- Ability to read blueprints and develop technical documents
- Experience with cGMP environments preferred
- LEAN, Six Sigma, ISO, or medical device experience is a plus
- Employee Stock Ownership Program (ESOP)
- Pension Plan + 401(k) Contribution
- Excellent medical benefits
- Employer-paid dental, vision, disability & life insurance
- Tuition reimbursement
- Wellness reimbursement
- Stable, growing organization with cutting-edge automation projects
- Flexible Friday schedule (half days!)
? Compensation: $72K–$100K depending on experience
- Do you have experience writing and executing DQ/IQ/OQ/PQ validation protocols in a cGMP environment?
- Have you participated in FAT and SAT activities for manufacturing equipment?
- Do you have experience creating technical documentation such as FDS, SDS, HDS, validation protocols, or operator manuals?
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Meet Your Recruiter
Team Lead and Principal Recruiter
Ric is a Team Lead and Principal Recruiter at Sterling Engineering with more than a decade of technical recruiting experience, including over eight years with Sterling. In his role, he leads recruiting efforts while also working hands-on with clients and candidates throughout the full hiring process.
From sourcing hard-to-find technical talent to navigating offer negotiations, Ric focuses on creating strong, lasting matches that benefit both the individual and the organization. His approach is built on understanding technical environments, listening closely to hiring needs and career goals, and aligning the right people with the right opportunities.
Ric enjoys recruiting because of the meaningful impact it can have on someone’s career. Whether helping a candidate pursue a growth opportunity, improve work-life balance, or step into a leadership role, he is driven by the opportunity to support people through important career decisions. At the same time, he takes pride in helping companies build high-performing teams that move their business forward.