What are the responsibilities and job description for the Validation Engineer position at Proximate Technology?
Validation Engineer
Work Setting: Onsite / Hybrid
Industry: Medical Device / Life Sciences
Job Summary
We are seeking an experienced Validation Engineer to support validation activities within a medical device manufacturing environment. The candidate will be responsible for developing and executing validation protocols, analyzing results, preparing validation reports, and ensuring compliance with applicable FDA and quality-system requirements.
Key Responsibilities
- Develop and execute IQ, OQ, and PQ protocols for equipment, processes, and systems.
- Support process validation (PV) and equipment qualification activities.
- Prepare validation plans, protocols, reports, and other technical documentation.
- Perform risk assessments and support FMEA activities.
- Investigate validation deviations, non-conformances, and failures.
- Develop and execute test procedures and validation test scripts.
- Work with Manufacturing, Quality, Engineering, and Regulatory teams.
- Support CAPA, change control, and deviation investigations related to validation.
- Ensure validation activities comply with applicable FDA 21 CFR Part 820, ISO 13485, and company procedures.
- Maintain accurate validation documentation and traceability.
- Participate in audits and provide validation-related documentation when required.
- Support equipment, facility, utility, software, and/or cleaning validation activities as applicable.
Required Qualifications
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Electrical Engineering, Pharmaceutical Engineering, or a related field.
- Experience in medical device, pharmaceutical, biotechnology, or regulated manufacturing environments.
- Hands-on experience with IQ/OQ/PQ and validation documentation.
- Knowledge of GMP, FDA regulations, and ISO 13485.
- Experience with CAPA, Change Control, Deviations, and Risk Management.
- Strong technical writing and documentation skills.
- Ability to work cross-functionally with Quality and Engineering teams.
Preferred Qualifications
- Experience with process validation and equipment qualification.
- Knowledge of 21 CFR Part 11 for computerized systems.
- Experience with CSV / Computer System Validation is a plus.
- Knowledge of ISO 14971 and medical-device risk management.
- Experience with GAMP 5 is a plus.
- Experience using tools such as TrackWise, Veeva, MasterControl, SAP, or similar quality systems.
Pay: $45.00 - $60.00 per hour
Benefits:
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Work Location: In person
Salary : $45 - $60