Manufacturing Associate II

Company: Kelly Services
Location: Dublin
Posted on: January 9, 2022

Job Description:

Kelly has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary position with a new client that is seeking a **Manufacturing Associate II in Dublin, CA** . If interested/available, please reach out to me directly at bryh262@kellyservices.com. Pay Rate: $24-$27/hr W2 - based on experience level Shift: Mon-Fri (4am-1230pm) Duration: 12/27/2021 - 06/26/2022 Location: On-Site **Job Summary** Provide technical assistance to the Humira Bulk Drug Substance (BDS) Manufacturing areas (Inoculum, Fermentation, Capture, Purification, Buffer & Media Formulation, Weigh & Dispensing and Glass Wash & Autoclave) related to the manufacturing process and equipment. The position requires dealing with difficult technical problems in a highly technical and regulated Biologics Plant. This position requires developing and implementing changes that will improve equipment performance and consequently product quality in the BDS manufacturing areas and reduce manufacturing costs, maintaining a constant product turnover. Develop and modify procedures as needed to support the manufacturing operation. Participate in process, equipment, and facilities validations efforts and projects implementations. Investigate process exceptions or equipment malfunction incidents affecting the process. Maintain the Manufacturing area equipment in compliance with the calibration and maintenance programs. Participate in the internal EHS and Quality audits. **Major Responsibilities** + Comply with Abbvie Corporate and Divisional policies and procedures, ABL Plant procedures, and regulatory agencies regulations and requirements. + 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 SOP's 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. + Help the Area Supervisor in the batch record audit process and discrepancies closures. Provide assistance during Regulatory Agencies Audits. **Position Accountability** + Demonstrated ability to contribute in a multi-disciplinary team environment. + Should have a high degree of initiative and responsibility which would enable incumbent to perform efficiently with a minimum of supervision. + Project Management Skills - Ability to take programs from concept to execution and manage all stages. Provide leadership to assigned teams by communicating and providing guidance towards achieving group objectives. + Provide technical assistance to maintain manufacturing equipment and process continuity avoiding losses due to poor production equipment performance. + Incumbent must work with other groups (ex. Maintenance, Engineering, Quality, Validations, Technical Operations/Tech Center, Computer Systems) influencing them to achieve their objectives to implement equipment and process improvements and at the same time, maintain a constant product turnover. **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 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 equipment's troubleshooting. + Previous experience with Control Systems; Delta V and MES preferable. **Mental & Physical Abilities** 1. Incumbent will deal with difficult technical problems in a highly technical and regulated biologics plant. 2. Must have the ability to focus, take initiative, cope with stress, and use judgment to accomplish results. 3. Excellent interpersonal skills that will permit effective interaction with peers, contractors, and customers. 4. Proven ability to effectively meet project goals by established dates in team setting. 5. Provide a team environment as to maintain highly motivated work force. 6. Must be able to communicate in English, both oral and written. 7. Excellent skills for managing teamwork with other departments of interaction. 8. Skills to operate computer automated systems. 9. Skills to understand technical information, in English. 10. Computer knowledge (Power Point, Excel, and Microsoft Word). 11. Ability to work with multiple priorities in a work environment with frequent interruptions. **Lifting requirement: 25 lbs (rare)** --- Assembly experience --- Basic GMP/GDP --- Tech savvy --- Good with email --- Some Excel **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 interests-it's 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Keywords: Kelly Services, Dublin , Manufacturing Associate II, Other , Dublin, California