Process Engineering Manager
Company Summary: This growing Medical Device Company is in search for a Process Engineering Manager who will embrace their company mission of saving lives, healing, and giving hope to those who receive their product. This company is top in the US at what it does, working with organ procurement, human tissue, and regenerative medicine. This company provides organs, tissues and cells for transplant, are innovators in the world of bio-implants, regenerative medicine and research, and improve the overall donation experience in the process. This company has over 1,000 employees and are working to continue their growth by adding more faces, more square footage, and increasing overall activities at their sites.
The Process Engineering Manager Manager will have the following responsibilities:
- Daily management of formulating, developing and implementing process improvements, to include involved equipment design/development and process validations, in accordance with applicable regulatory requirements.
- Make certain all activities are in compliance with FDA Good Tissue (GTP)/ Good Manufacturing Practices (GMP), ISO regulations, and AATB standards.
- Provide leadership to your team by leading employees to be effective and efficient team members by giving everyone the right skills necessary for completing their duties.
- Leads teams to carry out the transfer of new processes and products from Product Development to Production and Logistics. Formulate and carry out process validation protocols in accordance with generally accepted regulatory principles. You will also review, give feedback, and approve validation protocols.
- Lead your staff to execute assigned projects of varying complexity and scope, while managing multidepartment project teams in identifying and carrying out process and equipment improvement opportunities
The Process Engineering Manager will have the following qualifications:
- Bachelor's Degree in either Engineering, Life Sciences, Business Management, or related field
- CAPM or PMP Preferred
- 5 - 7 years of management experience, leading direct reports (including coaching and training)
- 3 years of experience with Process Engineering; experience with Med Device, Pharma or Biotech preferred
- 3 - 5 years of Project Management and Validation experience
- Experience in a Clean Room/Aseptic environment preferred
Company Benefits & Perks:
- Pension Plan
- Medical, dental, and vision coverage
- Generous paid time off
- Tuition reimbursement
- Personal career and skill development opportunities