Technical Leader, Operations
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Job Location:
Greenville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
12 hr shift/daysEnvironmental Conditions
Able 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.)Job Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
GROUP/DIVISION SUMMARY
The 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 SUMMARY
The 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
- Bachelors 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.
Must be legally authorized to work in the United States without sponsorship of any kind now or in the future.
Must be able to pass a comprehensive background check which includes a drug screen.
Key Skills
- Problem Management
- ISO 9001
- Process Improvement
- Warehouse Experience
- Business Management
- Project Leadership
- IT Service Management
- Project Management
- Strategic Planning
- DoD Experience
- Clamp Truck
- Leadership Experience
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
