Process Engineer - iMPact Business Group

Position Description

 This role is within our clients Product Transfer team. The role contributes to the delivery of high impact, cost transformative projects. The role will require the successful candidate to operate across a network of stakeholders from Product Transfer, Operations and Divisional partners, therefore strong interpersonal skills and communication skills will be necessary.

MAJOR DUTIES/RESPONSIBILITIES:

• Providing engineering support for product transfers ensuring that all activities are completed and documented in accordance with the company's latest procedures.
• Determining the technical objectives of engineering assignments and making decisions regarding the direction and the results of the assignment.
• Monitoring and controlling progress of work ensuring sound application of engineering principles and the appropriate use of policies and procedures.
• Analyzing equipment to establish operating data, conducting experimental test and result analysis.
• Leading or acting as independent reviewer in process review meetings.
• Coaching and mentoring others on functionally related topics.
• Ensuring quality of process and product as defined in the appropriate operation and material specifications.
• Selecting components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Working with quality engineers to develop component specific testing and inspection protocols.
• Participating in PFMEA, Control Plan, SOP, PPAP and other internal process qualification generation associated with product transfers.
• Ensuring adherence to GMP and safety procedures.
• Reviewing and approving of validation documentation.
• Owning and supporting the development of the validation plan for highly complex validation projects.
• Owning and supporting validation and initial qualification of equipment and systems as related to new equipment for NPI/Product Transfer activities.
• Writing, reviewing, and executing studies for process validation, including DOE, OQ, and PQ.

REQUIREMENTS

• Bachelor's degree in an engineering discipline.
• Minimum of 4 or more years' experience in an FDA regulated manufacturing or project environment, medical device industry is highly preferred.
• Experience with process/ equipment validation - IQ/OQ/PQ, FAT/ SAT testing.
• Experience with statistical methods, process mapping, root cause analysis.
• Experience coaching and mentoring team members, managing and coordinating projects, workstreams and activities.
• Experience with setup, programming, troubleshooting PLC's, ladder logic.
• Experience sourcing new equipment - URS, RFQ, etc.
• Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
• Continuous Improvement and Project / Process Improvement related experience, preferred.
• Green or Black Belt 6 Sigma qualifications, preferred.
• Experience with SCADA systems, preferred.

REQUIREMENTS

• Bachelor's degree in an engineering discipline.
• Minimum of 4 or more years' experience in an FDA regulated manufacturing or project environment, medical device industry is highly preferred.
• Experience with process/ equipment validation - IQ/OQ/PQ, FAT/ SAT testing.
• Experience with statistical methods, process mapping, root cause analysis.
• Experience coaching and mentoring team members, managing and coordinating projects, workstreams and activities.
• Experience with setup, programming, troubleshooting PLC's, ladder logic.
• Experience sourcing new equipment - URS, RFQ, etc.
• Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerancing.
• Continuous Improvement and Project / Process Improvement related experience, preferred.
• Green or Black Belt 6 Sigma qualifications, preferred.
• Experience with SCADA systems, preferred.