Manufacturing Associate II

Company: Randstad USA
Location: Dublin
Posted on: January 13, 2022

Job Description:

Job Details:
Manufacturing Associate II in Dublin, CA
6 Months Contract

Job Summary:
Provide technical assistance to the 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 Company 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 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 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.

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's Degree in Sciences (i.e.. Biology, Chemistry, Engineering).
Proven ability to effectively meet manufacturing goals by establishing dates in a 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 biotechnology, pharmaceutical, or health care plant.
Previous experience in manufacturing processes of biotechnological drugs, aseptic operations, parenteral drugs, solutions preparation, and sterilization operations is preferable.
Knowledge in manufacturing equipment troubleshooting.
Previous experience with Control Systems; Delta V and MES preferable.

Mental & Physical Abilities:
The incumbent will deal with difficult technical problems in a highly technical and regulated biologics plant.
Must have the ability to focus, take initiative, cope with stress, and use judgment to accomplish results.
Excellent interpersonal skills that will permit effective interaction with peers, contractors, and customers.
Proven ability to effectively meet project goals by establishing dates in a team setting.
Provide a team environment to maintain a highly motivated workforce.
Must be able to communicate in English, both oral and written.
Excellent skills for managing teamwork with other departments of interaction.
Skills to operate computer automated systems.
Skills to understand technical information, in English.
Computer knowledge (PowerPoint, Excel, and Microsoft Word).
Ability to work with multiple priorities in a work environment with frequent interruptions.

Keywords: Randstad USA, Dublin , Manufacturing Associate II, Other , Dublin, California