Sterile Specialist, Engineering (Onsite)

Job Description

This Engineer position will provide on-site engineering support of the Rahway NJ FLEx (Formulation Laboratory & Experimentation) center for sterile operations within Our Companys Research Labs Pharmaceutical Sciences (Pharm Sci) Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift) work is required to meet the operational needs.

The FLEx facility supports the formulation and filling of clinical stability and developmental supplies for sterile products 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. Areas supported include FLEx Sterile1 with operational readiness in 4Q2025 and a secondary focus on FLEx Sterile2 currently in capital project phase. Pharm Ops Engineering serves to provide support for quality engineering equipment reliability and maintenance and sterilization and cleaning validation.

The primary responsibility of this role is to maintain facility utilities and manufacturing equipment in accordance with GMP and Safety requirements while applying Reliability Maintenance best practices to ensure timely availability of clinical and development batches. This will require equipment troubleshooting and routine interaction with Partner Groups such as GES (Global Engineering Services) Facilities Management (FM/GWES) and Original Equipment Manufacturers (OEM) and vendors.

The individual is to provide support for Quality Engineering (QE) and capital project. This includes interfacing with site engineering and maintenance groups as well as external vendors to support ongoing operations upgrades and installation of new capital equipment. The role will support the full equipment validation lifecycle (from commissioning through decommissioning) by preparing executing and approving protocols. Responsibilities also include managing equipment/system changes performing periodic reviews. Evaluate deviations issue Quality Notification (QN) perform investigations identify root causes and any related corrective actions/ preventive actions (CAPA). Maintain GMP documentation where applicable such as GMP engineering drawings and equipment database tracking. Support the mechanical aspects of clinical operations. Coordinate activities executed by maintenance personnel and contractors/ vendors. Support gatekeeping of work orders. Manage purchase orders supporting budgets and asset depreciation. Support capital project administration including processing capital requests and managing project closeout activities. Coordinate installation upgrades and commissioning of new capital equipment. Support regulatory interactions as a Subject Matter Expert (SME) when needed.

Additional responsibility will be to support the sterile validation program both sterilization and cleaning. The program will leverage third-party support (vendor) for execution activities and consultation on program details and requirements. Individual will function as Subject Matter Expert (SME) on validation of equipment used for sterilization and cleaning in clinical drug product manufacturing. Own author and/or review validation SOPs protocols and summary reports. Perform technical assessments for new parts or soil matrix. Help coordinate field execution and align necessary equipment and instruments. Address any issues or challenges from conceptual to approval.

Education Minimum Requirement:

• Bachelors degree in engineering or science plus a minimum of 2 years of related Drug Product/Sterile/Validation experience.

Required Experience and Skills:

• Strong familiarity with Quality cGMP Safety & Environmental Policies and Procedures.

• Familiarity with Sterile Drug Product manufacturing equipment and process.

• Familiarity with Computerized Maintenance and Management Systems (CMMS).

• Troubleshooting ability (mechanical/electrical/automation)

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

• Effective organizational skills.

• Effective communication and technical writing skills.

• Strong computer skills

Preferred Experience and Skills:

• Maintenance & Engineering techniques and management and Capital Project management.

• Independent problem- solving.

• SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)

• eVal/Kneat - Paperless electronic validation system

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

• Familiarity with Planning and Scheduling practices as well as business/financial practices.

• The candidate should be able to work independently and lead or facilitate tasks successfully.

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

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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