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30 days old

Process Lead, Sterile/Non Sterile Operations

Kelly Services
Manatí, PR 00674
**Process Lead, Sterile/Non Sterile Operations**


Provides operational support for Operations Area (Formulation, Filling Inspection, and Packaging Operations as applicable) on a shift-by-shift basis in order to meet production requirements. Accountable for providing operational, scientific expertise and compliance knowledge support to the Sterile or Non Sterile Manufacturing Operations. Also accountable to lead Low Investigations task items and support Corrective Action Preventive Action (CAPAs) assigned to Process Improver team.


Support Area Supervisors to coordinate with the area planners and quality personnel, to organize and comply with daily production goals.Ensures Operations personnel on his/her shift complies with the established GMPs curriculum to achieve proper knowledge transfer and personnel qualification such as but not limited to aseptic techniques, Isolation technology, TFF, lyophilization, sanitization, inspection and packaging as applicable. Ensures that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in order to achieve optimal operational performance while maintaining regulatory and compliance requirements. Area must be Audit Ready at all times. Partners with MS&T, Eng and PMO to achieve sterile and/or non-sterile strategic growth product projects milestones. Assures a streamlined and continuous operation between Sterile Operations and Non Sterile Operations. Supports all technology transfer activities, equipment qualification and process validation, troubleshooting clinical lots production, and process optimization by providing the necessary process expertise.Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).


Requirements:


BS Degree in Chemistry, Biology, Engineering, Pharmacy or related sciences. -Sterile Support: 5 years of experience in aseptic processes, isolation technology, including lyophilization, within a pharmaceutical environment. In-depth technical knowledge of the aseptic filling process, sterilization, isolation technology and lyophilization process. Extensive knowledge and understanding of manufacturing processes associated with parenteral products in conventional aseptic and lyophilization technology.


Non Sterile Support: 5 years of experience in inspection and packaging operations in a pharmaceutical environment. In-depth technical knowledge of the inspection, device assembly and packaging process.


*Willing to work on any work shift and day of the week: 12 hours shift, might be 5:00am to 5:30pm or 5:00pm to 5:30am. Rotating Days.


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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.

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Posted: 2021-05-21 Expires: 2021-06-21

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Process Lead, Sterile/Non Sterile Operations

Kelly Services
Manatí, PR 00674

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