Thermo Fisher Scientific Process Engineer III - Compliance in Lexington, Massachusetts
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Viral Vector Services (VVS), a division of Thermo Fisher Scientific, is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
What will you do?
The Process Engineer III will report directly to the Process Engineering Manager. Key responsibilities include supporting ongoing manufacturing, quality control, and facilities operations by leading investigations (owning deviations), identifying corrective and preventive actions (CAPA), and managing the program for Engineering sponsored changes. The PE III will lead the entire Engineering and Facilities compliance responsibilities and leverage their experience with process design and management to drive the group's Key Process Indicators.
How will you get there?
Responsible for the daily management of compliance commitments including driving the implementation of external commitments, leading deviation investigations, and working cross functionally to support on time release of product.
Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
Ensure high levels of communication with team, support resources and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
Partner with technical leadership, program management and clients to implement product / process improvements; participates and/or may lead cross functional projects. Acts as engineering subject matter expert for assessments for change controls, validation protocols, and document changes.
B.S. degree in chemical engineering, mechanical engineering, biochemical/biomedical engineering, electrical engineering, automation engineering, or related engineering field and minimum of 5 years of related industry experience is required. Advanced degree plus 3 years or equivalent industry experience.
Minimum of 2 years in cGMP operations, engineering or maintenance teams in fast paced production environment.
Experience with process equipment and operations such as bioreactors, filtration systems, chromatography skids, filling equipment etc. is required.
Experience supporting biologic manufacturing processes within an FDA/EMA regulated environment.
Demonstrated ability to manage cross-functional teams and collaborate across the business.
Strong analytical and problem-solving skills; great attention to detail and excellent decision making process.
Expertise in managing small and medium technical and/or capital projects.
Demonstrated ability to present ideas persuasively and negotiate effectively.
Excellent written and oral communication skills both internal and external.
Knowledge, Skills, Abilities
Ability to function in a dynamic environment and balance multiple priorities simultaneously.
Ability to learn new software and tools quickly.
Ability to make decisions and work with minimal to moderate supervision.
Ability to aseptically gown and/or sterile gown as needed.
While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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