Senior Manufacturing Engineer

Position Overview:

As a Manufacturing Engineer, you will play a pivotal role in optimizing and streamlining our biotechnological manufacturing processes. You will work closely with cross-functional teams to ensure that our production lines run efficiently, meet stringent quality standards, and align with regulatory requirements. Your expertise will contribute to the development and improvement of innovative biotech products, ensuring their successful transition from development to commercial manufacturing.

Key Responsibilities:

1. Process Optimization:

   • Analyze and improve existing manufacturing processes to enhance efficiency, reduce waste, and increase product yield.
   • Develop and implement new manufacturing processes and technologies to support product innovation and scale-up.

2. Quality Assurance:

   • Ensure that all manufacturing activities comply with Good Manufacturing Practices (GMP) and other regulatory requirements.
   • Troubleshoot and resolve production issues, including deviations and non-conformances, to maintain product quality and consistency.

3. Equipment Management:

   • Oversee the installation, calibration, and maintenance of manufacturing equipment and instrumentation.
   • Collaborate with the maintenance team to ensure that equipment is functioning optimally and to minimize downtime.

4. Documentation and Compliance:

   • Prepare and maintain comprehensive documentation, including process validation reports, standard operating procedures (SOPs), and batch records.
   • Participate in internal and external audits to demonstrate compliance with regulatory standards.

5. Cross-Functional Collaboration:

   • Work closely with R&D, Quality Assurance, and Supply Chain teams to support product development and ensure smooth transitions from pilot to full-scale production.
   • Provide technical support and training to manufacturing staff to ensure effective implementation of new processes and technologies.

6. Project Management:

   • Lead or contribute to projects aimed at improving manufacturing processes, such as capacity expansion, cost reduction, and technology upgrades.
   • Monitor project progress, manage timelines, and ensure that project deliverables meet quality and performance standards.

Qualifications:

• Education: Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biotechnology, or a related field. Advanced degree preferred.
• Experience: Minimum of 3-5 years of experience in a manufacturing engineering role within the biotechnology or pharmaceutical industry.
• Technical Skills: Strong understanding of biotechnological manufacturing processes, equipment, and regulatory requirements. Experience with process optimization, lean manufacturing, and Six Sigma methodologies.
• Problem-Solving: Excellent analytical and problem-solving skills with a proven ability to troubleshoot complex manufacturing issues.
• Communication: Strong interpersonal and communication skills, with the ability to work effectively in a team-oriented environment.
• Attention to Detail: High level of attention to detail and accuracy in documentation and process execution.

Preferred Skills:

• Experience with bioprocessing, cell culture, or purification processes.
• Familiarity with automation and control systems used in biotech manufacturing.
• Certification in Six Sigma or Lean Manufacturing.

Working Conditions:

• This role may involve working in a manufacturing environment, which could include exposure to chemicals, biological agents, and other manufacturing-related hazards. Personal protective equipment (PPE) will be provided and required.