Job Description :
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
As part of the Thermo Fisher Scientific team, you'll 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 world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our team at Thermo Fisher Scientific as a Engineer II, Technical Operations, where you'll contribute to innovative scientific solutions. You'll perform complex manufacturing and formulation activities in a GMP environment, working with advanced technologies to develop and produce high-quality biopharmaceutical products. This role offers the opportunity to enhance processes while maintaining rigorous quality standards. You'll work with colleagues across functions to ensure successful technology transfers, process validation, and commercial manufacturing operations. We're seeking detail-oriented professionals dedicated to serving science and enabling our customers to make the world healthier, cleaner, and safer.
RESPONSIBILITIES:
- Supports inNPI (New Product Introduction) or existing product byparticipatingin validation, qualification activities of products and processes, re-qualificationactivitiesand quality investigations. Responsible to author technical Operations protocols, reports and other documentations related to existing product or NPI at site.
- Provide training to Operation team necessary to support manufacturing and process activities.
- Demonstratesexpertiseingood technical writing skills with respect to reports, protocols, qualityinvestigationsand change requests.
- Provide technicalexpertisefor day-to-day production activities of commercial products,e.g.Support inidentifyingroot causes of problemsusing appropriateproblem solvingtools changes and improvements to processes implementation of new production technologies etc.
- Provides technicalexpertisefor quality compliance activities (fore.g.documentation update to batch records, SOPs, risk assessmentsetc.), change control, investigations andCAPAand support for health authorities inspections.
- Demonstrates and proactivelyparticipatein Continuous Process Verification (CPV) and Annual Product Review (APR) activities to trend,monitorand analyze and adjust and shift in processparameters, critical quality attributes (CQAs) and process and equipment performance. Must be familiar with usingappropriate statisticaltools to read and reactonthe trends.
- Participates incritical technical projects related to the production of commercial sterile pharmaceuticals.
- Ensures that new products/processes introduced into production are robust and efficient. It follows and supports from atechnicalpoint of view or the engineering andvalidationbatchesin order toensure the robustness and efficiency of the transferred processes.
- Participation in projectmeetings,aimed at transposing the production processes requested by the customer, the approval of the instructionsregardingproduction operations, anysupportin the event ofanomalies with respect to production standards.
- Demonstrate and promote EHS safe practices as per safetystandardsSOPs. Ensure all the activities are carried out as per EHS standard and site safety SOPs. Participate in safety activities, HAZOPS and process safety activities related to the product at site
- Any other duties assigned bymanager.
REQUIREMENTS:
- Advanced Degree with no prior experience required, or Bachelor's Degree plus 2 years of experience in pharmaceutical/biotechnology manufacturing or laboratory environment
- Preferred Fields of Study: Chemistry, Biology, Biochemistry, Biotechnology, Chemical Engineering or related scientific field
- Demonstrated expertise in GMP manufacturing processes and documentation practices
- Strong understanding of aseptic techniques and clean room operations
- Proficiency with analytical instruments and methods (HPLC, PCR, cell culture, etc.)
- Experience with process validation and technology transfer activities
- Excellent documentation and data analysis capabilities
- Strong troubleshooting and problem-solving skills
- Ability to work independently and collaborate effectively in cross-functional teams
- Clear written and verbal communication skills
- Proficiency with Microsoft Office applications and laboratory information systems
- Ability to lift up to 20 lbs regularly and occasionally up to 45 lbs with assistance
- Flexibility to work varying schedules including some weekends/holidays as needed
- Knowledge of relevant regulatory requirements (FDA, EMA, etc.)
- Experience with process improvement methodologies (Lean, Six Sigma) preferred
- Strong organizational skills and attention to detail
- Ability to train and support team members
