Senior Process Engineer

Scismic is supporting a rapidly growing biotechnology company developing innovative therapeutic materials for advanced medical applications.

The company is seeking a Senior Process Engineer to lead the development, optimization, and continuous improvement of manufacturing processes while providing technical leadership and mentorship to the engineering team.

This role involves translating product concepts into scalable manufacturing processes, managing process design and validation, and leading technology transfer and commercialization efforts. The position requires a mix of strategic planning, hands-on technical expertise, and leadership in regulated environments.

Key Responsibilities

• Demonstrated expertise in strategic planning, business development, and resource allocation
• Advanced proficiency in MS Office, statistical software packages, and process modeling tools
• Outstanding communication skills, organizational abilities, and executive presence
• Exceptional interpersonal and public speaking skills with proven ability to present to senior leadership
• Advanced aptitude in decision-making, problem-solving, and conflict resolution
• Must have exceptional verbal, writing, and presentation skills with ability to communicate complex technical concepts to non-technical audiences
• Comprehensive understanding of business functions such as Quality, Regulatory, Operations, Supply Chain, and Finance
• Expert knowledge of FDA, AATB, ISO, cGMP, and other applicable regulatory guidance and requirements
• Proven leadership and team management capabilities
• Strong business acumen and understanding of P&L impacts

Qualifications:

Education

• Required:
  Bachelor's of Science Degree in Engineering (Mechanical Engineering, Chemical Engineering, Electrical Engineering, Industrial Engineering, or Manufacturing Engineering preferred) or related technical field
• Preferred:
  Master's degree in Engineering or related technical discipline, or MBA

Work Experience

• Required:
  8-10 years of progressive experience in process development, optimization, and validation within a highly regulated environment such as biologics, medical devices, pharmaceuticals, or food manufacturing
• Required:
  Minimum 3 years of people management or team leadership experience
• Required:
  Demonstrated product development experience from concept through commercialization, including participation in new product launches and lifecycle management
• Proven track record of translating product concepts and R&D innovations into scalable manufacturing processes
• Experience collaborating with R&D teams during early-stage product development to ensure manufacturability and design for manufacturing (DFM) principles
• Advanced statistical background with expertise in data analysis, root cause analysis, Design of Experiments (DOE), and statistical process control
• Demonstrated experience leading cross-functional project teams and managing multiple complex projects simultaneously
• Proven track record of successful process scale-up from laboratory to commercial manufacturing, including pilot-scale and commercial-scale product launches
• Experience with technology transfer and site-to-site process transfers
• Extensive experience with Lean Manufacturing and Six Sigma methodologies for continuous improvement initiatives
• Experience developing and implementing process automation and advanced process control strategies
• Six Sigma Black Belt certification preferred; Green Belt minimum required
• Experience with risk management methodologies (FMEA, Risk Assessment)
• Budget management and capital project experience preferred
• Experience supporting regulatory submissions (510(k), PMA, BLA, IND) with manufacturing and process development sections

Position Type and Expected Hours of Work

This is a full-time exempt position. Standard hours of work are Monday through Friday, 9 a.m. to 5 p.m., with flexibility required to meet project deadlines and business needs. Position requires minimum 40 hours per week with additional hours as needed for project demands, equipment installations, or critical manufacturing support.

Travel

Travel is primarily local during the business day, although regular out-of-the-area and overnight travel should be expected (approximately 10-20% of time). May include attendance at industry conferences, vendor sites, contract manufacturing organizations, and regulatory meetings.