What are the responsibilities and job description for the Process/Validation Engineer position at Collabera?
The Process/Validation Engineer will be responsible for providing engineering production support, implementing process and technology improvements, and ensuring compliance with regulatory standards. This role involves process and cleaning validation, equipment qualification, change control, and data analysis to drive process efficiency, quality, and compliance.
Key Responsibilities:
- Conduct process and cleaning validation activities and equipment qualification (IOQ/PQ).
- Support manufacturing processes through data collection, analysis, and performance monitoring.
- Investigate non-conformances, CAPAs, and process deviations; implement corrective/preventive actions.
- Manage change control processes and ensure compliance with quality systems.
- Apply statistical analysis tools (e.g., Minitab, JMP) for process improvement.
Required Skills & Experience:
- 3-5 years' experience in Medical Device or Pharmaceutical industries (Medical Device preferred).
- Proficiency in Quality Systems such as Veeva, Trackwise, and ComplianceWire.
- Knowledge of FDA, ISO, ISPE, and other relevant regulations.
- Strong skills in statistical methods, root cause analysis, and technical writing.
- Bachelor's degree in Engineering, Science, or related field.
Preferred Skills:
- Six Sigma, Lean Manufacturing, DOE, and Value Stream Mapping experience.
- Expertise in biological products, aseptic processes, and process monitoring.
- Strong organizational, time management, and communication skills.
Pay Range: $40/hr to $45/hr
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).
Salary : $40,000 - $60,000