Senior Specialist, Engineering

* Oversee improvement projects and implementation of productivity enhancement initiatives.
* Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment uptime, minimizing cost and maintaining process consistency
* Anticipates and interprets client and/or customer needs to identify solutions
* The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving.
* Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)
* The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root causes.
* Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Maintenance, Automation, and Quality approvers.
* As part of the deviation management role, present and defend investigations during regulatory inspections, as required.
* Actively supports safety initiatives, including shop floor audits, lockout/tagout and Hazardous Energy Control Procedure updates
* Proficient in PI Processbook, Siemens BAS, and DeltaV
* Project management, including change control and equipment qualification
* SAP experience related to plant maintenance and spare parts procurement systems
* cGMP experience in a sterile, bulk or finished pharmaceutical environment
* Experience authoring PM/calibration job plans and management of spare parts
* Mechanical functionality and reliability knowledge (asset management)
** Los Angeles Residents Only:
** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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