Job Description

This is a FT opportunity with a major Pharma leader...key role within the company.

Responsible for providing technical support and project support to Operations, Facilities Engineering, Product Development, Quality, and Regulatory Affairs.  This position will focus on improving and optimizing operations, providing support in areas such as data analysis identification of potential process bottlenecks and vulnerabilities, investigations into process abnormalities, and troubleshooting.  Knowledge of cGMPs is essential.  Experience with GMP manufacturing is essential.

Identify and rectify process and equipment bottlenecks

Serve as the internal primary subject matter expert for CIP/SIP

Act as the lead for new projects for CIP/SIP

Participate in troubleshooting and start-up of Process Equipment

Provide on-call support for Operations on an as needed basis.

Provide and analyze metrics for equipment downtime as necessary.  Provide technical input for solutions to increase throughput.

Participate in cross functional teams dedicated to process improvement, efficiency, and optimization.

Provide technical assessments for investigations, validation, and change control Supervise the creation and reconciliation of Preventive Maintenance work orders done by the Facilities staff.

Supervise the creation, maintenance, and reconciliation of complete equipment service files and associated O and M (operation and maintenance) files

Collect and organize technical data from equipment manufacturers, equipment users, and engineering personne

Supervise the selection, purchase, organization, and replenishment of department spare parts .

Manage corrective actions as a result of investigations.

Execute studies and comparability protocols for manufacturing operations.Author and revise procedures for the Preventive Maintenance program to meet cGMP requirements.

Generate and revise control documents to support process equipment and manufacturing processes.

Monitor the implementation of all revised SOP’s by ensuring timely training and documentation.

Perform all necessary follow up actions, on behalf of the Facilities Department, for system audits performed by outside departments.

Conduct audits of potential service providers for the purpose of determining suitability of services, as needed.

Qualifications

The position is based in San Diego with travel requirements in/outside the US.

Min 15 years of relevant cGMP and technical experience in facilities / space planning 

BS degree in technical fields such as Engineering, Biology, Chemistry 

Knowledge of  process equipment design as it pertains to CIP/SIP

1. Experience with pilot-scale pharmaceutical/ biopharmaceutical process equipment
2. general and with respect to Preventive Maintenance/Metrology requirements within the pharmaceutical industry.
3. Detailed knowledge of automated recall systems used to manage regularly occurring maintenance tasks for equipment and systems.
4. Ability to organize personal tasks and concurrently monitor service providers /assignments.
5. Ability to read and interpret engineering drawings and specifications.
6. Knowledge of the operation and maintenance of equipment typical to the Bio- Pharmaceutical industry including, but not limited to; high purity water generation and storage systems, pure steam generation and distribution systems, waste receiving and treatment systems, high pressure boiler and H.V.A.C systems, high purity compressed air systems, Autoclaves, cell culture bioreactors, chromatography equipment, and general laboratory support equipment and instruments

Additional Information

Please attach a WORD resume to your on-line application.

This is a FT position with a major Pharma leader

1099 OR W2.  NO!  AGENCIES PLEASE...

All your information will be kept confidential according to EEO guidelines.