Process Engineer

Report To:    Engineering Manager

Department:  Operations Management 451

The Process Engineer will perform activities for the development of new products, the transfer of new technologies, and the implementation of process improvements. All Engineering activities must be in compliance with FDA, GMP, ISO and Corporate Quality System regulations.

Strategic Focus Areas:

  • Maintain effective collaboration with internal departments to meet corporate objectives and to drive improved business results
  • Design and implement programs, processes, and activities which support the growth efforts of the Company.
  • Maintain cost discipline within assigned programs and projects

Specific Tactical Responsibilities:

  • Collaborate with Research & Development to develop appropriate design outputs that meet deadline requirements
  • Conduct design verification activities at laboratory and pilot scale to define product performance characteristics and develop commercial processes
  • Design and modify processes to cost effectively produce products which meet critical product attributes; perform experiments to screen critical process control factors; develop robust processes at the laboratory scale
  • Develop detailed procedures for the new processes and work; prepare appropriate specifications for materials, components and product testing
  • Design, specify and test equipment required to manufacture product
  • Lead or participate in project teams in the development, optimization, transfer and validation of processes to pilot scale
  • Maintain detailed documentation throughout all phases of development; prepare comprehensive development reports detailing procedures, test methods, and results of activities according to Quality System requirements
  • Maintain current design control documentation meeting Anika requirements and industry standards
  • Prepare specifications for new equipment and coordinate start-up and validation activities; prepare operating procedures for new equipment and processes
  • Lead the process design efforts for new manufacturing concepts
  • Identify and qualify new materials for the manufacturing of medical device products
  • Other projects and activities as required

Job Complexity:

The job requires the ability to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals.  The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.

Supervisory Responsibilities:

No direct reports, however, must be able to participate in multi-disciplined project teams and manage vendors, contractors and consultants as required.  In the area of product design, must be able to lead multi-disciplined project teams.

Required Qualifications:

  • Bachelor’s degree in Chemical Engineering or related field
  • 3-5 years of experience in a medical devices or pharmaceutical company in a product/process development role
  • Experience in design and specification requirements of pilot and commercial scale equipment for medical device and pharmaceutical industries
  • Knowledge and experience with the FDA requirements for commercialized products
  • Demonstrated project management skills and results orientation

 Desired Experience, Knowledge, and Skills:

  • Knowledge of hyaluronic acid –related products is preferred
  • Knowledge of aseptic processing and/or process optimization and process scaling involving high viscosity hydrogels is also beneficial
  • Experience in early stage product development, including the scientific, regulatory and clinical hurdles to commercialize product concepts is preferred
  • Experience qualifying new materials, including container closure
  • Strong understanding of process controls and equipment automation (PLCs)
  • Proven professional communication skills – listening, oral and written
  • Strong analytical and organizational skills
  • Proactive problem definition and creative problem solving skills

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We are an Equal Employment Opportunity Employer