23 days old

Manufacturing Associate

Kelly Services
Barceloneta, PR 00617
Major Responsibilities

Provide technical assistance to the manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh & Dispensing and Glass Wash & Autoclave).

Assist in the troubleshooting of the manufacturing equipment and process.

Investigate process and equipment exceptions and follow up CAPA implementation.

Revise SOPs and PCR and submit Change Requests (CR) for approval.

Develop and implement changes that will improve equipment performance and consequently product quality in the Bulk Drug Substance Manufacturing Areas (Upstream, Downstream and Central Services Areas) and reduce manufacturing costs.

Evaluate and implement new equipment technology.

Establish requirements and assist in the implementation of changes to the Process Control System.

Participate in the development and execution of validation protocols. Participate in the manufacturing personnel training.

Give direct support to the manufacturing process and trouble shootings.

Provide assistance to the Area Supervisor in the batch record audit process and discrepancies closures. Provide assistance during Regulatory Agencies Audits.

Educational Requirements

Bachelor Degree in Sciences (i.e.. Biology, Chemistry, Engineering).

Proven ability to effectively meet manufacturing goals by established dates in team setting.

Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, and EN46000), knowledge of corporate, local, state, and OSHA regulation.

Excellent verbal and written communication skills in both, English and Spanish.

Experience Requirements

At least two (2) years five (5) years of experience in the manufacturing environment of a biotechnology, pharmaceutical or health care plant.

Previous experience in manufacturing processes of biotechnological drugs, aseptic operations, parenteral drugs, solutions preparation, and sterilization operations preferable.

Knowledge in manufacturing equipments troubleshooting.

Previous experience with Control Systems; Delta V and MES preferable.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2022-05-04 Expires: 2022-06-04

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Manufacturing Associate

Kelly Services
Barceloneta, PR 00617

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