Technical Operations Specialist
1 day ago
We are seeking an experienced Technical Operations Specialist to join our team at Thermo Fisher Scientific. As a key member of our production team, you will be responsible for supporting the development and implementation of technical operations protocols, reports, and documentation related to existing products or new product introductions.
About the Role- 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.
- Minimum 2-5 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
$90,000 - $110,000 per year, depending on experience
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