21 days old


Kelly Services
Añasco, PR 00610
Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team.

Generation and execution of validation plans, validation protocols (FAT/SAT/IQ/OQ/PQ/CSVs), and completion reports. Provide statistical analysis of the date to support the reports.

Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

Review and approve validations and completion reports for new and existing products, processes and equipment.

Troubleshooting equipment/processes that do not perform as intended during validation runs.

Recommend process/quality improvements as part of validation runs.

Work with new and existing equipment, processes, utilities, facilities and cleaning validations, to include (but not limited to) freeze drying, CCA, DIUF, RO/DI, WFI, Pure Steam, SIP Systems, HEPA Filters

Education and/or experience:

BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.

PE License strongly desired.

Lean/Six Sigma Green or Black Belt Certification is a plus.

Experience in validations such as: manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, packaging, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required.

Minimum of 3 - 5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in a validation engineering position

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-11-04 Expires: 2020-12-05

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Kelly Services
Añasco, PR 00610

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