Manager, Quality Engineer

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the most significant investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

SCOPE OF ROLE/RESPONSIBILITY

The New Manager will lead the GMP Documentation, Master Batch Record, and Secondary Packaging team that involves the startup a new commercial manufacturing process and technology transfer.

Key Areas of Responsibility:

• Work with cross-functional teams to drive execution of capex project/tech transfer deliverables and produce required documentation (URs, P&Id, trial protocol, etc.)
• Lead collaborations with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product (new equipment qualifications, etc.)
• Be an owner of commercial product(s) and be accountable for Following internal SOPs and meeting regulatory requirements for the site’s manufactured products.
• Collaborate with Production, Technology Transfer, and Quality teams to create and revise the manufacturing instructions.
• Handle the master data related to the materials codes and the MBRs through the PMX system.
• Assess the impact of changes on manufacturing instructions
• Handle minor change requests for the improvement of master batch records
• Work with a proficient team on the introduction of new products as well as on the modification of documents related to validated products
• Specific tasks will be tailored to the person’s experience level and abilities
• Build and lead a team of experts who will work closely together and within a highly matrixed, cross-functional team to successfully deliver business objectives
• Drive continuous improvement activities and operational excellence

Qualifications:

• Engineering Master’s Degree, pharmaceutical or chemical master degrees with 7+ years of experience
• Prior experience in developing and/or managing engineers
• Experience with equipment design, commissioning, troubleshooting, etc for cGMP environment.
• Understanding principles for manufacturing combination drug product, and/or pharma batch processes.
• Fundamental understanding and application of technology transfer
• Strong communication (written and verbal), collaboration, and team building skills; ability to connect with all levels of the organization

• Benefits
• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
• 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.
• 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.
• We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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