Description
International key client of ours is looking for a PHARMACEUTICAL Validation Engineer for a 12 month contract in its Ohio location offering attractive hourly rates.PHARMACEUTICAL VALIDATION ENGINEER will:
Develop FACILITY, EQUIPMENT, ANALYTICAL, COMPUTER VALITION plans. Prepare validation protocols (IQ, OQ, PQ).
Responsibilities:
? Coordinate the proper approval of plans and protocols. Perform the execution of protocols.
? Prepare validation final reports.
? Support the QA department in any regulatory inspections or audits.
? Work with QA to track and coordinate re-qualification events.
? Document deviations, system failures, and corrective actions.
? Generate validation protocols (e.g. Val Plans, Requirements, final reports, Traceability Matrix, and
Retirement Plans) per approved policies and procedures.
? Apply a risk-based approach to develop validation strategies based on the intended use of a new or existing
system.
? Execute approved validation protocols (e.g. IQ, OQ, PQ) and document deviations, system failures, and
corrective action.
? Review completed protocols for completeness, cGxP compliance, and data acceptability.
? Ensure GxP systems remain in a validated state by reviewing proposed change controls, evaluating impact,
generating testing to verify the system still functions as expected.
? Resolve comments, deviations, and technical issues. Support the Quality department in any regulatory
inspections or audits.
? Support change control, configuration management systems, and re-validation events.
? Able to plan and schedule validation projects.
? Coordinate validation execution between all involved departments.
Qualifications:
? BS or MS in Engineering, Life Science, or Computer Sciences.
? 7+ years validation experience in an FDA validated environment.
? Prior experience in cleaning, computer, and/or automation validation strongly preferred. MUST BE IN PHARMACEUTICAL MANUFACTURING ENVIORNMENT
? Broad validation experience to support multiple functional areas within a pharmaceutical manufacturing facility.
? Ability to interface, lead, and communicate with multiple groups.
? Works independently and follows stringent timelines.
? Knowledgeable in cGLPs, cGCPs, cGMPs, validation principles and changes controls.
? Proficient in the use of Microsoft Word, Excel, Outlook, and Project.
? Excellent written and verbal communication skills.
? Detail oriented with a focus on quality and metrics.
? Flexible and able to work in a team environment.
? Excellent written and verbal communication skills.
Requirements:
Physical Demands
Ability to work a flexible schedule to support a 24/7 facility. Ability to sit for long periods of time reviewing andgenerating electronic and written data. Requires ability to transport up to approx 20 lb of equipment or documentation.
Manual Dexterity
Frequently use a computer keyboard, PDA, or other electronic device. Calibrate small components on machines or equipment. Ability to operate complex automated equipment.
Audible/Visual Demands
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.
Ability to distinguish between colors (e.g. warning lights onquipment). Ability to view and interpret screens/HMIs for entire shift. Hear audible equipment alarms.
Environment:
Manufacturing, Office, and Lab environments including clean rooms and chill rooms