Senior Specialist, Sterile Engineer (Onsite)

Job Description

This Sterile Pharm Operations Engineer position will provide engineering support to West Point (WP), Sterile & Liquids pilot plant (SLP) under the remit of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering).  Engineering group is responsible to maintain process equipment and facility in a validated state and to provide reliable uninterrupted business continuity.

The area supports the formulation and filling of clinical, stability, and developmental supplies for biologics and vaccines, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization.  

Primary responsibility will be to maintain all equipment in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best practices to ensure timely availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. 

Work collaboratively with various partner groups such as operations, equipment vendors, site maintenance, quality.  Support mechanical aspects of clinical operations, including shop-floor troubleshooting support, gatekeeping of work orders, placing and expediting expense purchase orders, managing budgets, asset depreciation, and coordinating mechanical work performed by maintenance personnel, contractors/vendors and facility operating staff.   Manage and perform lockout/tagout and hazardous energy control procedures.  Maintain GMP documentation where applicable, such as GMP engineering drawings, post-approved qualification documents, and equipment database tracking.  Facilitate and/or participate in deviations reporting, investigations and any related corrective action/preventive action (CAPA).  Facilitate equipment/system change controls, execute periodic reviews and support Quality Management System (QMS) activities. Provide technical expertise, troubleshooting and improved equipment reliability/performance.

Provide quality engineering support that includes collaboration with CQV team for equipment qualification.  Additional support includes to execute capital and expense equipment related projects. Provide capital project administration with necessary project information and updates (processing capital requests and administering capital project closeout activities). 

Interface with site engineering and maintenance groups, as well as outside service providers to create maintenance and calibration data build.  Establish partnership with contractors, vendors, outside service providers to manage service level agreements.  Ensure appropriate equipment spare part inventories are established and maintained as required.   

Education Minimum Requirement: 

• Bachelor's degree in Engineering or Science plus a minimum of 5 years of related sterile experience.

Required Experience and Skills: 

• Familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.

• Technical writing: investigations, change requests, standard operating procedures, etc. 

• Maintenance & Engineering techniques and management 

• Ability to flexibly adapt to flow to the work across both Quality and Facility aspects to support the business.  

• Demonstrated skills in problem-solving and troubleshooting

• Effective organizational and communication skills (verbal and written).

• The candidate should be able to work independently.

Preferred Experience and Skills: 

• Familiarity with Capital Project systems (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). 

• Knowledge and experience of sterile drug product manufacture

• SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance

• Experience with ProCal as the Computerized Calibration Maintenance System (CCMS).

• Equipment qualification experience in support of good manufacturing practices.

• The candidate should be able to lead or facilitate tasks successfully

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Po