Process validation engineer

job summary:
Shape the future of healthcare by joining our client, an industry leader innovating healthcare technology, as a Process Validation Engineer in Mahwah, NJ. Requires strong technical writing capabilities to author IQ/OQ/PQ protocols and drive impactful process improvements.

location: Mahwah, New Jersey
job type: Contract
salary: $35.48 - 45.00 per hour
work hours: 8am to 5pm
education: Bachelors


responsibilities:

• Develop and modify process formulations, methods, and controls while integrating equipment capabilities to meet quality standards and target specifications.
• Author, execute, and close IQ/OQ/PQ protocols for production lines and equipment.
• Collect and analyze experimental data using statistical methods, compile validation final reports, and evaluate Engineering Change Orders (ECOs) for re-validation impact.
• Draft and update work instructions, SOPs, preventative maintenance procedures, and equipment operating manuals based on validated parameters.
• Partner with cross-functional engineering teams to review product development requirements, estimate costs/schedules, and document new technology processes.

qualifications:
Degree in Mechanical Engineering (entry-level) with proficient technical writing skills for SOPs, validation protocols, and technical reports.

Ability to work under pressure, collaborate effectively with engineering teams, and assist in creating and updating process documentation for new technologies.

Hands-on, mechanically inclined background with experience or knowledge in IQ/OQ/PQ validations, design review, and PLM software (e.g., OnePLM/Windchill) preferred.

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 View email address on click.appcast.io.


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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.