Full Job Description
Description:
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 Client 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.
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 Preference for Engineering, or Sciences (i.e.. Biology, Chemistry, highly preferred 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
Job Type: Contract
Pay: $20.00 - $25.00 per hour
Schedule:
8 hour shift
Monday to Friday
Contract Length:
5 - 6 months
Contract Renewal:
Likely
Benefit Conditions:
Waiting period may apply
