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Position Summary:This growth role is available in Manufacturing Science & Technology’s (MSAT’s) Process Engineering department at Thermo Fisher Scientific.Qualified individuals will lead a small team of downstream process engineering and help support activities for customer programs executing GMP batches. This role will require cross-functional work with Process development, QA, operations, quality control, engineering, and process validation to ensure GMP execution is performed appropriately according to site policies and regulations.The candidate has core competency in downstream process engineering (protein purification) processes and leadership.Key Responsibilities:Directly or indirectly managed customer programs.
Guide the team and provide support in technical requirements for technical transfer to manufacturing and PPQ programs.
Engage the team to work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, ultrafiltration, and depth filtration.
Represent Process Engineering and assist juniors in Internal and Customer meetings and make sound evidence-based contributions.
Actively drive engineering initiatives to improve practices and procedures. Participate in MSAT maturity projects and global initiatives.
Monitor the process performances and out of trend results.
Provide technical support for GMP deviations. Help devise and Implement Corrective Actions.
Draft and Review procedures via Process Flow Diagrams, Standard Operation Procedures, and Job Aids and Batch Records ensuring the process is technically accurate and Designed for Manufacturing
Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
Provide on-floor technical support for manufacturing processing, as needed.
Perform performance reviews and regular 1:1 meeting.
Participate in hiring.
Minimum Requirements/Qualifications:6+ years of Process Engineering/Project Management experience in the pharmaceutical manufacturing (or similar) industry.
Proven previous experience leading a team
Solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing.
Must possess a high level of proficiency in a technical core competency.
Excellent verbal and written communications skills with the ability to build and drive direct and cross-functional teams.
Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting.
Competencies:Experience in managing complex engineering projects through direct and cross-functional teams.
Knowledge and experience in a regulated environment to ensure regulatory compliance is achieved. GMP experience is preferred.
Familiar with upstream and downstream bioprocess operations and equipment.
Define process requirements and establish project design criteria based on engineering analysis and evaluation. Prepare detailed functional specifications.
Physical:5% - 15% Travel may be required.
Risk of exposure to chemicals in a plant environment.
Work around biopharmaceuticals, chemicals, plant utilities equipment and at construction sites.
Education:Chemical Engineering or Biochemistry Bachelor degree required. Other engineering or science degrees will be considered based on relevant work experience.Master or PhD degree preferred - minimum experience requirements will be adjusted.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Vacancy expired!