Shire Jobs

Job Description

How will you make an impact?

We are searching for a Process Engineer 2 with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes. A Process Engineer 2 routinely supports the Process Engineering team as technical owners of customer programs in a manufacturing environment and will assist in defining and shaping Thermo Fisher Scientific’s own technology programs. This role will collaborate with internally with supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and occasionally with the client. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.

What will you do?

• Draft Standard Operation Procedures, and Job Aids.

• Collaborate with the process development to assess standardized methodologies and learn new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.

• Contribute to Internal and Customer meetings based upon sound evidence guided by supervision.

• Manages internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.

• Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.

• Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.

• Lead changes to equipment and process design.

• Draft, review and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.

• Draft Process control documents, campaign summary report and process validation reports

• Reviews, analyzes and trends process data with minimal supervision

• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.

• Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.

• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.

• Provides development and training for Process Engineers/Scientists.

How will you get here?

Education

• Bachelor’s degree required in a scientific field, preferably an engineering field.

• 2+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree in a scientific field).

• Or 6 years equivalent experience

Experience

• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment.

• Ability to self-motivate, prioritize work and time.

• Demonstrates a foundation in general scientific practices, principles, and concepts.

• Writes and communicates effectively.

• Ability to work both independently and as part of a team.

• Knowledge of current Good Manufacturing Practices and US/EU regulations.

• Novice knowledge of statistical methods used for Pharmaceutical Process Analysis is a plus.

• Proficient in Microsoft Word and Excel.

• Ability to stand for prolonged periods of time and gown into manufacturing areas.

Relocation Benefits

This position does not offer relocation benefits.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodation in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

• This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.