What are the responsibilities and job description for the Validation Engineer position at Randstad Life Sciences US?
Validation Engineer
Location : Rockford, IL
Term : 6-month contract (Extendable)
Schedule : 8 AM – 5 PM (Hybrid)
Pay Rate : $60 / hr
Key Hiring Notes :
Protocol Writing : Experience developing, executing, and documenting validation protocols (IOQ, OQ / PQ) for equipment, processes, and computer systems.
Medical Device Experience Preferred (Pharma Also Considered) : Preference for medical device experience (Auto-Injector preferred), but candidates with pharma backgrounds will be reviewed.
Previous Validation Engineering Experience : Minimum of 3 years in a regulated industry (FDA, cGMP, pharmaceutical, medical device, or combination products).
ISO Standards Knowledge & Compliance : 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.
Job Description
The Validation Engineer is responsible for overall project ownership of validation efforts for high- through low-risk projects under limited to no supervision. Responsibilities include generating and executing validation protocols, assisting in audits, determining validation needs, and training analysts. This position has no supervisory responsibilities.
Essential Duties and Responsibilities
Perform validation activities to ensure compliance with government and customer requirements.
Prepare and execute validation protocols (IOQ, OQ / PQ) and related documentation for new customer / product / system launches.
Maintain existing validated processes, coordinating 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 to communicate project goals and progress.
Investigate validation deviations, document formal reports, and ensure corrective actions are completed.
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) to qualify equipment.
Coordinate validation efforts with mechanics, operators, and engineering teams.
Complete and pass GDP and GMP training courses as required.
Perform other duties assigned by managers or supervisors.
Manage high-risk projects, which may include complex customer needs, stringent validation requirements, and significant time commitments.
Special Demands
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.
Work Environment
Primary Work Setting : Office environment (50–75% of the day).
Additional Settings : Moderate risk areas requiring protective gear for up to 25% of the day.
Exposure to Moving Parts : 25–50% of the day.
Noise Level : Very quiet.
Qualifications
Required :
Education : Bachelor’s degree in a related field or 1–3 years of related experience and / or training.
Mathematical Skills : College-level proficiency.
Computer Skills : Intermediate skills, including proficiency in various technical software programs.
Language Skills : Full professional proficiency in speaking, reading, and writing.
Preferred :
Experience with medical device sterilization processes and test method validation.
Familiarity with GAMP, 21 CFR Part 11, Annex 11 compliance for computer system validation.
Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
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