This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Responsibilities:
- Support NPI (New Product Introduction) by participating and leading development studies, cleaning process development, and qualification activities.
- Demonstrate in-depth knowledge of change controls, cleaning validations, qualifications, and process performance trending and reporting.
- Author technical operations protocols, reports, and other documentation related to existing products or new product introductions.
- Act as a mentor to guide junior engineers in handling NPI, quality investigations, CPV, and problem-solving tools.
- Collaborate with production managers to optimize yields, improve plant flexibility, and minimize costs while adhering to GMP, budget, and safety standards.
- Demonstrate expertise in technical writing for reports, protocols, quality investigations, and change requests.
- Lead significant quality investigations and act as a technical reviewer for change controls.
- Provide technical expertise for day-to-day production activities, including root cause analysis, process improvements, and implementation of new technologies.
- Support quality compliance activities, including documentation updates, change control, investigations, and CAPA.
- Supervise and review CPV and APR activities to monitor and adjust process parameters and equipment performance.
- Ensure continuous improvement in production structure by proposing actions related to plant layout, GMP adaptation, and cost optimization.
- Participate in critical technical projects related to commercial sterile pharmaceuticals production.
- Serve as the main interface on technical issues between technical operations and customers.
- Ensure robust and efficient transfer of new products/processes into production.
- Participate in project meetings to transpose customer production processes and support the production process improvements.
- Promote EHS safe practices and ensure safety adherence to standards and SOPs.
- Perform any other duties assigned by the manager.
Educationand Experience
- Minimum bachelor's degree in engineering, biological/chemical sciences or related fields.
- Minimum 2 to 5 years of pharmaceutical experience
- Knowledge of pharmaceutical manufacturing processes and GMP
- Experience in statistical process controls and related tools
- Good digital literacy
- Knowledge of safety and environmental regulations
- Flexibility and leadership skills
- Positive relationship skills and attention to detail
- Experience in sterile injectable drug production and packaging/visual inspection preferred
- Highly motivated to work in the pharmaceutical industry
- Ability to work as part of a team
