Process SME, Manufacturing Engineering

Work Schedule

Environmental Conditions

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.