Senior Specialist, Manufacturing Engineer (Onsite)

Job Description

The Rahway FLEx (Formulation Laboratory & Experimentation) Center is a flexible agile facility that brings together capabilities operations and talent to accelerate the pipeline

Pharmaceutical Operations & Clinical Supply is seeking applicants for a Manufacturing Engineering Lead to support specialty dosage forms and oral solid dosage (OSD) GMP development activities on second shift. The successful incumbent will serve as the technical lead for shift production coordinating safety quality and equipment decisions. This role evaluates safety product/process quality and equipment performance and determines the appropriate path forward to protect patients people and compliance.

Key Responsibilities

• Own technical decisions for the shift and act as the primary production engineering point of contact for NonSterile operations.

• Evaluate safety quality and equipment status; make realtime technical determinations on next steps including stopwork when risk warrants; escalate and document per cGMP expectations.

• Serve as owner and trainer for key equipment with emphasis on specialty setups (e.g. spray drying autoinjector assembly potentprocessing isolators).

• Lead room readiness and equipment readiness: plan/execute room setup; equipment assembly/disassembly; cleaning; line clearance; changeover.

• Author execute and close GMP documentation (batch records logs investigations CAPA change controls); ensure data integrity in MES (e.g. PASX) and ALCOA principles.

• Troubleshoot equipment/system issues and drive rootcause analysis with peer specialists formulation scientists facility engineers and automation engineers; implement robust corrections/preventive actions.

• Coach and develop the shift team by actively sharing knowledge standardizing best practices and identifying improvements that strengthen safety quality delivery and cost.

• Lead improvement activities on one of the specialty equipment trains in the oral solid dosage facility

• Champion Ways of Working and continuous improvement; lead small projects from scoping through qualification and handover.

• Approves equipment disposition (repair replace optimize) based on condition reliability and product requirements; coordinates with Maintenance/Facilities Automation production process engineering and formulators.

Minimum Qualifications

• Bachelors degree in Engineering or Science (e.g. Mechanical Chemical Biomedical) or equivalent GMP manufacturing experience.

• 5 years in GMP clinical or commercial manufacturing (OSD or specialty dosage forms) with handson equipment setup cleaning and troubleshooting.

• Demonstrated knowledge of cGMP data integrity batch documentation investigations and CAPA.

• Experience with OCT FCT and encapsulation manufacturing; spray dryers autoinjector assemblies isolators (OEB4/OEB5) or comparable specialty equipment.

• Strong problem solving and rootcause analysis skills; ability to lead and train operators/technicians on the floor.

• Ability to work second shift onsite in classified GMP suites.

Preferred Qualifications

• MES experience (e.g. PASX) and proficiency with electronic logbooks and quality systems.

• Exposure to potent compound handling and containment strategies; respirator/gowning certification a plus.

• Lean/Six Sigma certification or practical application; familiarity with TPM/RCM and basic reliability tools.

• Working knowledge of EHS risk assessment (JSA/WRAs) and equipment qualification/validation basics.

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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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