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Manufacturing Associate

Company: ATR International
Location: Dublin
Posted on: January 10, 2022

Job Description:

Job Description We are seeking a Manufacturing Associate II. 2nd shift - 12:00pm to 8:30pm Pay - $25.00 to $29.00 Job Duties - 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 the company's 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. Provide assistance to the Area Supervisor in the batch record audit process and discrepancies closures. Provide assistance during Regulatory Agencies Audits. The ideal candidate will possess the following qualifications: 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. - Assembly experience - Basic GMP/GEP - Tech savvy - Good with email - Some Excel Company Description ATR International is a staffing and consulting leader that serves the IT, engineering, accounting & finance, professional, manufacturing, and scientific industries. Founded in 1988 as a two-person Hispanic-owned business, we have grown to serve Fortune 500 organizations while putting more than 35,000 people to work totaling over 14 million working hours. Our entire business model is based on building relationships and deep connections with our diverse base of clients, contractors, internal staff, and local markets.

Keywords: ATR International, Dublin , Manufacturing Associate, Other , Dublin, California

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