Engineer II, Manufacturing

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

Job Title: Quality Engineer II

Location/Division Specific Information

This position is within the Engineering Department of Thermo Fisher Scientific in Groningen.

Looking for our new team member!

Our site in Groningen is part of the extraordinary Pharma Services of Thermo Fisher Scientific, and we are looking for a new colleague for our Validation & Plant Engineering team. We operate in a sophisticated and highly regulated environment. You’ll do important work, like helping customers in finding cures for cancer, protecting the environment!

You will have a real-world impact, and you’ll be supported in achieving your career goals. Pharma Services offers our clients a powerful platform for their drug development with technologies that are industry standard to groundbreaking.

Our facility follows rules and regulations of cGMP set by countries health and welfare ministries and with internationally harmonized guidelines that give guidance with implementing these and the EH&S requirements and regulations.

Thermo Fisher Scientific Biologics Groningen exclusively focuses on production of antibodies and other active pharma proteins using mammalian cell lines. New technologies are acquired and/or developed to keep and increase the competitiveness of our business.

Controlled production activities and compliance to cGMP rules, regulations and guidelines is critical for the suitability of the clients’ products and the license to operate for the site. In addition, due to the very high value of intermediates and products, production activities have to be performed in a highly controlled fashion.

How will you make an impact?

As a Quality Engineer, you will lead investigations, develop investigation plans, and support the development of corrective action plans for quality topics related to engineering, equipment. systems, facilities, manufacturing investigations as well as corrective action requests, and quality improvement initiatives. You will work closely with internal customers and multi-functional teams to ensure our products meet customer inputs.

Discover Impactful Work:

• Lead multi-functional Teams: Prioritize customer feedback/complaint handling and CAPA processes.
• Quality Improvements: Ensure execution of actions to address product quality, including customer communication.
• Conduct Risk Assessments: Perform and detail risk and impact assessments for product and process improvements.
• Work with Team members: Lead customers/internal teams to address quality issues.
• Problem-Solving Expertise: Develop solutions using tools such as 8D, 5-Whys, and cause-and-effect analysis.
• Motivate Change: Champion changes to improve quality and efficiency.
• Influence and Negotiate: Work productively to resolve issues, gain agreement, and drive continuous improvement initiatives.
• Communicate Decisions: Present recommendations and outcomes to teams and leadership efficiently.

How will you get here?

Education

• Bachelor’s degree in an Engineering field, OR 2-4 years of direct Quality Engineering experience.

Experience

• 3+ years in the medical device, biotech, or pharmaceutical industries in Quality, Engineering, or Regulatory roles.
• Experience with Quality management systems, and 21 CFR 820 requirements.
• Specific knowledge of bio-pharmaceutical processes, and pharmaceutical guidelines

Knowledge, Skills, and Abilities

• Strong analytical and problem-solving capabilities.
• Validated knowledge of quality systems, continuous improvement methodologies, and process/product understanding.
• Expertise in data analysis and decision-making.
• Familiarity with bio pharmaceuticals, bioprocess equipment, water systems, HVAC and utilities, and manufacturing processes
• Ability to handle and prioritize meaningful demands efficiently.
• Excellent interpersonal, communication, organizational, and influencing skills.
• Extraordinary teammate
• Planning and organization of own work
• Results oriented
  • Physical Requirements
  • On site. Ability to move around the facility.

  Why Join Us?

  At Thermo Fisher Scientific, every one of our 70,000 extraordinary minds has a unique story to tell. Join us and give to our singular mission: enabling our customers to make the world healthier, cleaner, and safer.

• What we offer:

• 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 while empowering team members. We offer an exciting company dynamic that stands for integrity, intensity, involvement, and innovation!

  We encourage candidates that enjoy working in a diverse, multi-disciplinary, groundbreaking technology environment where personal development and team collaboration are key to success.

  Diversity in our teams is an important element to build an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key values that we expect of all that are part of our community.