• Full Time
  • Indiana

Website GeniPhys

Empowering tissue generation

Manufacturing Engineer

POSITION OVERVIEW:

The Manufacturing Engineer will be responsible for supporting process
development and operations in a GMP certified manufacturing facility for
collagen-based medical products. They will support the manufacture of
the base polymerizable collagen protein and associated collagen
materials, ensuring production, performance, and quality standards are
consistently met. Initial responsibilities will focus on finalizing process
steps, documenting, and validating the manufacturing process for
commercial production. This individual will interface with product
development and quality and regulatory team members to ensure that
company goals and objectives related to regulatory submissions and
product launch are achieved.

QUALIFICATIONS:

Required: BS in engineering or equivalent

Preferred:

  • MS in engineering or equivalent
  • Manufacturing process engineering experience in GMP environment
  • Protein purification, biologics, and/or medical device manufacturing experience
  • Familiarity with medical device quality management systems
  • Familiarity with ISO 13485

Skills & Competencies:

  • Process engineering
  • Process design
  • Equipment validation and qualification
  • Project management skills
  • Able to identify problems and develop potential solutions
  • Strong communications skills
  • Cross-functional team leadership
  • Collaborative skills
  • Attention to detail

Duties/Responsibilities:

  • Develops and implements equipment qualification and validation protocols
  • Assist in transitioning lab scale manufacturing process to pilot scale in new facility
  • Facility startup activities
  • Developing equipment specifications, ordering and receiving equipment
  • Accountable for compliance with appropriate GMP and other regulations and standards
  • Develop and evaluate potential process improvements with a focus on efficiency and quality
  • Execute manufacturing protocols consistently and in accordance with cGMP
  • Identifies areas for improvement and works with appropriate team members to implement
  • Performs other related duties as assigned

To apply for this job email your details to andyeibling@geniphys.com

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