Manufacturing Associate II
Company: Randstad USA
Posted on: January 13, 2022
Manufacturing Associate II in Dublin, CA
6 Months Contract
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
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.
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
Investigate process and equipment exceptions and follow-up CAPA
Revise SOPs and PCR and submit Change Requests (CR) for
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
Provide assistance to the Area Supervisor in the batch record audit
process and discrepancies closures. Provide assistance during
Regulatory Agencies Audits.
Demonstrated ability to contribute in a multi-disciplinary team
Should have a high degree of initiative and responsibility which
would enable incumbent to perform efficiently with a minimum of
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
Provide technical assistance to maintain manufacturing equipment
and process continuity avoiding losses due to poor production
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.
Bachelor's Degree in Sciences (i.e.. Biology, Chemistry,
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
At least five (5) years of experience in the manufacturing
environment of biotechnology, pharmaceutical, or health care
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
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
Must be able to communicate in English, both oral and written.
Excellent skills for managing teamwork with other departments of
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
Keywords: Randstad USA, Dublin , Manufacturing Associate II, Other , Dublin, California
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