Senior Process Engineer

GForce Life Sciences; Tempe (AZ); On-site; USD 85,000 - 110,000; Full time

Job summary

GForce Life Sciences in Tempe, AZ is seeking a Manufacturing Engineer for a 12-month contract onsite at least 3 days per week. You will provide engineering support for new product introductions and ensure documentation aligns with new product development procedures.

Responsibilities include ensuring process and product quality, assisting in equipment selection, supporting capital projects, writing manuals, and performing PFMEA/PPAP activities, with emphasis on GMP compliance and safety.

Qualifications

• 2+ years of relevant manufacturing/engineering experience.
• Bachelor's degree in Engineering is required.

Responsibilities

• Provide engineering support for new product and process introductions.
• Ensure quality of process and product per specifications.
• Assist in equipment selection and design based on specs and regulatory requirements.
• Support capital acquisition activities including equipment specification, negotiation, and validation.
• Drive GMP and safety adherence at the manufacturing site.

Skills

Engineering

GMP compliance

Regulatory awareness

Education

Bachelor's degree in Engineering

Tools

DFM

Validation techniques

MSA

Statistical tools

Job description

Location: Tempe, AZ
Duration: 12-month contract
Work Arrangement: Onsite at least 3 days per week (some flexibility)

Responsibilities

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with established new product development procedures.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Assist in the selection and design of equipment based on analysis of specifications, reliability, and regulatory requirements.
• Support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
• Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals.
• Analyze equipment to establish operating data and conduct experimental test and result analysis.
• Use engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines and product costs.
• Participate in process review meetings.
• Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches.
• Complete capability studies for in-process inspection and generate subsequent inspection documentation.
• Conduct qualifications, validations, and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation.
• Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development.
• Drive and execute effective communication with all stakeholders to enable project success.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.

Required Qualifications

• 2+ years of relevant work experience.
• Bachelor's degree in Engineering.

Preferred Qualifications

• Lean Six Sigma Green Belt Certification or above.
• Knowledge of manufacturing processes, materials, product, and process design.
• Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques.
• Experience writing and executing validations.
• Experience in new product introduction or manufacturing engineering.
• Experience in an FDA-regulated or regulated industry.