We are seeking a skilled Validation Engineer to lead validation efforts for a new drug delivery site. This role involves protocol development and execution, audit support, validation assessments, and analyst training, all under limited to no supervision. The ideal candidate will have a strong background in GMP compliance, regulatory standards, and validation processes within the pharmaceutical or medical device industry.
Schedule/Shift: 1st shift, Mon.-Fri. (Hybrid)
Position Type: 6 mos. contract; potential to extend
Position Summary: The Validation Engineer is responsible for overall project ownership of validation efforts, working under limited to no supervision. This includes generating and executing validation protocols, assisting in audits, determining validation needs, and training analysts. This role has no supervisory responsibilities.
location: Elgin, Illinois
job type: Contract
salary: $55 - 60 per hour
work hours: 9 to 5
education: Associate
responsibilities:
- Perform validation activities to ensure compliance with government and customer requirements.
- Prepare and execute validation protocols (IOQ, OQ/PQ), validation standards, validation statements, reports, summaries, and the Master Validation Plan for new customer/product/system launches. Maintain validated processes and coordinate internal and customer approvals as needed.
- Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals.
- Assist in the change control process and prepare change control and validation history reports for audits.
- Participate in conference calls and meetings.
- Communicate project goals and progress to supervisors or managers. Investigate validation deviations, document them in formal reports, and ensure corrective actions are completed to resolve issues.
- Review and interpret standards, procedures, and specifications for validation protocol development.
- Review and approve User Requirement Specifications (URS), Functional Specifications (FS), and Engineering Study Protocols. Assist with Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for equipment qualification.
- Harmonize and streamline validation activities while coordinating with mechanics, operators, and engineering staff.
- Complete and pass GDP and GMP training courses as required.
- Perform other duties as assigned by the manager or supervisor.
- Manage high-risk projects that may include complex customer needs, significant time commitments, or stringent validation requirements.
qualifications:
- Bachelor's degree (BS) in a relevant field (Engineering, Life Sciences, or related discipline).
- Three (3) or more years of validation engineering experience in a medical device, biotech or pharmaceutical industry (FDA, cGMP, pharmaceutical, medical device, or combination products).
- Facility validation, utility validation and computer systems validation (CSV)
- Experience developing, executing, and documenting validation protocols (IOQ, OQ/PQ) for equipment, processes, and computer systems.
- Regulatory and Compliance knowledge. Understanding of ISO, cGMP, FDA, 21 CFR Part 11, Annex 11, and other regulatory standards.
- Risk Management expertise. Proficiency in root cause analysis (RCA), CAPA, FMEA, control plans, and process risk management.
- Proficiency in college-level mathematics for technical calculations.
- Intermediate to advanced computer skills with the ability to navigate various software programs.
- Full professional proficiency in English (reading, writing, and verbal communication).
- Medical Device (Auto-Injector experience)
- Medical device sterilization processes and test method validation
- Familiarity with GAMP, 21 CFR Part 11, Annex 11 compliance for computer system validation (CSV)
- Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
- Stationary Position: 50-75% of the day.
- Movement/Traversal: Up to 25% of the day.
- Operate/Inspect/Activate: Up to 25% of the day.
- Lifting/Transporting: Up to 10 lbs. occasionally (less than 25% of the day).
- Work primarily performed at a desk or office environment (50-75% of the day).
- Moderate risk or discomfort areas may require special safety precautions, such as protective clothing or gear, for up to 25% of the day.
- Proximity to moving mechanical parts: 25-50% of the day.
- Exposure to extreme cold (non-weather): Up to 25% of the day.
- Noise level: Very quiet.
skills: Biomedical Engineering, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
