Validation Engineer jobs in Paramus, NJ

• Permanent position for a Validation Engineer for pharmaceutical manufacturing equipment and controls.
• Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
• Work with company's control system programmers to develop and execute factory acceptance software test documents.
• Work as an integral member of a project team.
• Interface with the company equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development.
• Field execution and testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
• Coordinate the efforts of the personnel involved during on-site qualification.
• Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing.
• Prepare documents of field visits in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
• Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
• Develop, maintain, and enhance positive interpersonal relationships with staff members.

• BS Engineering or Science
• Minimum 5 years of related experience.
• Must posses a valid driver's license.
• Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
• Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential.
• Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.
• Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
• Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.
• Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).
• Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.
• Must be willing and be capable to climb ladders and to enter restrictive spaces.
• Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part.

About the Company:
Engineering Resource Group

We are different from all the other engineering staffing firms!

All of our account executives and recruiters have at least a four year engineering degree and at least five years engineering industry experience. This ensures the highest level of competence and professionalism in the staffing industry, delivering the best possible service to both our clients and our candidates.

Our account executives / recruiters average more than eight years of experience with us. This means that, if need be, the recruiter you work with today will be the same one you work with next year and five years from now.

Call us and speak to our management or to one of our recruiters and find out what we mean when we say:
“Engineering Staffing by Engineering Professionals, Since 1991”

Engineering Resource Group provides the industry with engineers and engineering support staffing for both contract / temporary and direct / permanent jobs.

Company Size:
100 to 499 employees

Industry:
Staffing/Employment Agencies

Founded:
1991

Website:
https://careers.terkotech.com/