Manager, Maintenance Excellence (Reliability Engineering)

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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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 . 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.

Location/Division Specific Information

Thermo Fisher Scientific's facility in St. Louis, MO, offers comprehensive services for developing and manufacturing biologic drugs. The 96,875-square-foot facility supports the entire process, from initial development to commercial production. It has extensive cell culture capabilities and can handle batch sizes from 100 grams to 20 kilograms using advanced single-use equipment.

The site is a leader in single-use technology, providing flexible options for scaling up production from 50 liters to 5,000 liters. The new 5,000-liter Dynadrive bioreactor, developed at the facility, showcases Thermo Fisher's expertise in biologics manufacturing and bioprocessing.

How will you make an impact?

We are searching for a Process Engineer   1   with   education   in biopharmaceutical processing , o r   a related   field . This member of our team   uses their   foundational knowledge in general scientific and engineering   principles   to   provide   technological input in   the    scale   up and   validation   of manufacturing process es.   A   Process   E ngineer   1 supports   the   Process   Engineering team as   technical owner s   of customer   programs in   a   manufacturing   environment   and   w ill   assist   in   defin ing   and shap ing   Thermo Fisher Scientific’s own technology programs.   This role will collaborate   internally   with    technicians   in the Operations department, Quality Assurance, fellow   Engineers,    and   scientists in Process Development. These activities are   conducted   in projects and involve teamwork with experts across functional groups to ensure project success.

What will you do?

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

- Demonstrate   initiative   and attention to   detail   and   an eagerness   to   learn new systems   and technolo gies .

- Attend   i nternal and   c ustomer meetings   g uided by   supervision , may   occasionally   present data .

- Manage internal projects and tasks   on time.   Actively   identify   error proofing opportunities   and   participate   in   driv ing   engineering initiatives to improve practices and procedures.

- Provide scientific   input   for   GMP   minor   deviations.

- Support   mock and quality audits

- Participate in   changes to equipment and process   design .

- Draft   Manufacturing Batch Records ,   P erformance   Q ualifications,   P rocess   V alidation protocols ,   Process flow diagrams, Automation methods,   and Bill of Materials ,   ensuring the process is technically   accurate   and   d esigned for Manufacturing .

- Performs daily dat a monitoring and data collection.   Troubleshoot technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility ,   including scheduled on-call support activities and occasional weekend coverage .  .

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

How will you get here?

Education

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

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.

- Fundamental k nowledge 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.