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 largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.
The Manufacturing Engineer 3 defines and implements process improvements, provides technical support to manufacturing operations, and improves manufacturing efficiency, reduces costs, and improves product quality. This role involves collaborating with multi-functional teams, ensuring GMP standards are met, and accurately detailing manufacturing processes.
Technical Responsibilities:
- Process Improvement: Identify and implement process improvements to enhance manufacturing efficiency, reduce costs, and improve product quality.
- Production Support: Technical support provided to manufacturing operations, resolving issues, and ensuring smooth production processes.
- Design and Development: Collaborate with design and development teams to ensure manufacturability of new products and processes.
- Lean Manufacturing: Implement lean manufacturing principles and practices to optimize production workflows and reduce waste.
- Quality Assurance: Work closely with quality assurance to ensure compliance with GMP standards and other regulatory requirements.
- Documentation: Develop and maintain accurate documentation of manufacturing processes, procedures, and work instructions.
- Data Analysis: Analyze production data to identify trends, root causes of issues, and opportunities for improvement.
- Training: Guide production staff about new processes, equipment, and standard methodologies to secure consistent and efficient operations.
- Collaboration: Partner with interdisciplinary teams, comprised of production, quality, design, and supply chain, to support overall manufacturing objectives.
- Equipment Maintenance: Be responsible for the maintenance and optimization of manufacturing equipment to guarantee reliable and efficient operations.
- Safety: Ensure all manufacturing activities are in line with safety laws and standard processes to sustain a safe working environment.
Quality:
- Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management (Deviations, CAPAs, Change Control, etc.).
- Actively chips in to continuous quality improvement initiatives and deviation reporting and follow-up.
- Represent the department as SME for the responsible area in audits and regulatory inspections.
EHSS:
- Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
- Actively supplies to safety initiatives and issues as well as near miss reporting and follow-up.
Values & Behaviour:
- Maintains dedication to Thermo Fisher Scientific values and alignment with ethics and legal compliance standards.
- Takes personal accountability for their presence, performance, and efficiency for the achievements of defined objectives.
- Thinks and acts with a customer-centric mentality.
- Is intellectually curious and accepts Practical Process Improvement (PPI).
Education:
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field.
Experience & Competences:
- Validated experience (5-7 years) in manufacturing engineering, preferably within the pharmaceutical or biotechnology industry.
- Validated experience in process improvement, production support, and equipment maintenance.
- Strong understanding of process automation and technical process operations.
- Extensive knowledge and professional experience with automation systems, particularly Siemens PCS 7 (knowledge of other Siemens systems, such as WinCC and TIA, is also required).
- Excellent planning and organizational skills.
- Strong communication and social skills.
- GMP experience is a must.
Additional Requirements:
- Ability to work independently and demonstrate job ownership.
- Analytical and concept-based thinking and acting.
- Physical ability to perform tasks that may require prolonged standing, walking, and lifting of materials and equipment.
- Proficiency in working in cleanroom environments and adhering to all GMP and safety laws.