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
Ric Delgado
Lead Technical Recruiter
Ric Delgado is a seasoned Principal Recruiter primarily focusing on the Automation Division at Sterling. With a distinguished tenure of over five years at Sterling and an impressive career spanning more than a decade in the recruiting field, Ric is a respected and accomplished professional in talent acquisition.
As a Principal Recruiter, Ric draws upon his extensive experience to excel in the Automation Division. His in-depth understanding of this dynamic industry enables him to connect talented individuals with exciting and fulfilling job opportunities expertly. Ric plays a pivotal role in helping candidates find new positions, advance in their careers, and achieve their professional goals.
Ric's passion for positively impacting individuals' lives through career advancement is the driving force behind his dedication to recruitment. He takes immense pride in his role as a professional growth and development facilitator, understanding the pivotal role a career change can play in a person's life journey.
He firmly believes in continuously updating one's skills and knowledge to stay competitive in any field. His commitment to personal and professional development not only enhances his own expertise but also positions him as a valuable resource for candidates seeking guidance in their career journeys.