Work Schedule12 hr shift/days
Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
GROUP/DIVISION SUMMARYThe Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
POSITION SUMMARYThe Technical Operations Lead serves as a key individual contributor supporting manufacturing and aseptic fill/finish operations for commercial drug products. This role provides hands-on technical expertise to drive reliable execution, optimize processes, support audit readiness, and ensure strong customer experience.
Operating without direct reports, this position partners closely with Manufacturing, Engineering, Quality, MS&T, and site leadership to resolve technical challenges, support regulatory inspections and customer audits, and improve operational performance. The role focuses on tactical execution, problem-solving, and cross-functional collaboration to meet production, compliance, and customer commitments.
Key Responsibilities- Serve as a technical subject matter expert in manufacturing operations, aseptic processing, and fill/finish technologies to support safe, compliant, and reliable production.
- Identify and implement technical improvements that enhance throughput, reduce downtime, and improve equipment and line performance.
- Provide hands-on troubleshooting support for complex operational issues, minimizing impact to schedule adherence and product supply.
- Partner with Quality and site leadership to ensure ongoing audit and inspection readiness, including preparation support, technical documentation review, and participation during regulatory and customer audits.
- Support customer interactions by providing technical expertise for investigations, deviations, change controls, and continuous improvement initiatives impacting product quality or supply.
- Assist in new product introductions, line expansions, and process changes by ensuring technical readiness and risk mitigation.
- Provide technical guidance and informal leadership to cross-functional teams while operating as an individual contributor.
Qualifications- Bachelor's degree in Engineering, Science, Operations Management, or related field preferred
- 8+ years of pharmaceutical manufacturing, technical operations, or quality experience required.
- Sterile fill/finish drug product experience required.
- Strong working knowledge of cGMP regulations and experience supporting regulatory inspections and/or customer audits.
- Demonstrated experience troubleshooting technical issues in a GMP manufacturing environment.
- Experience supporting customer communications, investigations, or technical responses preferred.
- Strong analytical and problem-solving skills with the ability to evaluate data and implement practical solutions.
- Excellent communication and collaboration skills, with the ability to influence cross-functional stakeholders without direct authority.
- Equivalent combinations of education, training, and relevant work experience may be considered.
Relocation Assistance is not provided. 
