Senior Production Process Engineer

7 days ago

Stockholm, Stockholm, Sweden Nordberg Medical Full time

As Senior Production Process Engineer, you will lead and support the development, optimization, and validation of manufacturing processes for Nordberg Medical's implantable Class III medical devices. This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques. You will play a crucial role in problem-solving and troubleshooting production issues while driving continuous improvement initiatives to enhance manufacturing capabilities while ensuring compliance with regulatory standards.

Key Responsibilities

Your responsibilities will include, but not be limited to:

Process Design and Development:

• Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.

• Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.

• Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).

Process Validation and Qualification:

• Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.

• Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.

• Analyze and document validation results, addressing any deviations or non-conformances.

• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.

Continuous Improvement and Optimization:

• Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.

• Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.

• Work closely with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Production, to align on process requirements and project timelines.

• Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.

• Collect and analyze production data to monitor process performance and identify areas for improvement.

• Generate reports, metrics, and presentations for management, summarizing process performance, validation activities, and improvement initiatives.

Regulatory Compliance and Documentation:

• Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines.

• Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.

• Participate in audits and regulatory inspections, providing technical support and documentation as required.

Equipment Management and Maintenance:

• Collaborate with maintenance and equipment teams to ensure that manufacturing equipment is maintained, calibrated, and performing optimally.

• Support the installation and validation of new equipment, ensuring it meets process requirements and regulatory standards.

Required Experience & Qualifications

  • Around 5-8 years of experience in process engineering, within the pharmaceutical or medical device industry with experience in at least Class III products.
  • Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
  • Proficiency in process design, documentation, and validation methodologies, including IQ/OQ/PQ.
  • Strong understanding of GMP, ISO 13485, FDA 21, and other applicable regulatory requirements.
  • Experience with pharmaceutical cleanroom operations – Class A to C.
  • Fluency in English (verbal and written).

Beneficial Qualifications

  • Experience in freeze drying and sterilization processes in the pharmaceutical industry, preferably EtO and E-beam.
  • Experience with statistical process control (SPC), Design of Experiments (DOE), and root cause analysis.
  • Familiarity with CAD software and process simulation tools.
  • Advanced skills in data analysis and reporting.

Personality

  • Analytical Thinking: Strong problem-solving skills with an analytical approach to process development and troubleshooting.
  • Attention to Detail: High degree of precision and adherence to quality standards in process design and documentation.
  • Communication Skills: Effective written and verbal communication skills, with the ability to present complex information clearly and concisely.
  • Collaboration: Ability to work effectively with cross-functional teams in a collaborative environment.
  • Initiative and Leadership: Self-motivated, proactive, and capable of leading projects with minimal supervision.

Other Information

  • You will be based in a production or manufacturing facility with a combination of office and on-floor work.
  • The role will involve occasional travel to supplier sites or other company locations as required.

Why Should You Join Our Team?

  • Impact: You'll have a unique chance to join us at an early stage, during an extensive expansion of both product range and volume.
  • Continuous Development: We are committed to fostering your professional growth through ongoing training and development opportunities, ensuring you have the resources and support needed for continuous learning and success.
  • Entrepreneurial Environment: Join a global, inclusive team where innovation and creativity are actively encouraged, empowering you to make a meaningful impact.
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