Senior Engineer, Process Engineering – Individual Contributor

Dexian; Maricopa (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Dexian is seeking a Senior Engineer, Process Engineering in Tempe, AZ to lead process development for new products on site. You will support equipment selection, validation, PFMEA, and SOPs while ensuring GMP compliance and collaboration with cross-functional teams.

The role requires 2+ years of related experience, a B.S. in engineering, and preference for Lean Six Sigma Green Belt and FDA-regulated industry experience. This is an onsite, 12+ month opportunity with potential extension.

Qualifications

• 2+ years of relevant work experience
• Bachelor’s degree in engineering
• Lean Six Sigma Green Belt or above preferred
• Knowledge of manufacturing processes and design for manufacturing
• Experience in FDA-regulated industry preferred

Responsibilities

• Provide engineering support for new product introductions and process development.
• Ensure quality of process and product per specifications.
• Assist in equipment selection and design based on specs and reliability.
• Support capital projects including equipment specs, contracts, installation, and validation.
• Write operations manuals and maintenance documents.
• Conduct PFMEA, control plans, SOPs, and PPAP for transfers/ launches.
• Perform capability studies and validation MSAs.
• Train manufacturing team and ensure GMP and safety compliance.

Skills

Manufacturing processes

DFM

Statistical methods

Validation techniques

Process engineering

Education

Bachelor's degree in engineering

Industrial or Systems Engineering degree preferred

Job description

Job Title: Senior Engineer, Process Engineering

Job Duration: 12+ Months (Possibility of Extension)

Location: Tempe AZ (Onsite)

Job Description: Client Sustainability Solutions Advanced Operations team is seeking to hire a Senior Process Engineer, Advanced Operations to work on new product introduction process development in Tempe, AZ. This role supports the execution of assigned project elements with an emphasis on the manufacturing process, technology, and procedures required for the manufacture of new products.

What you will do:

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Client 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.

What you need:

• 2+ years of relevant work experience required
• Bachelors degree in engineering required
• Bachelor's degree in Industrial or Systems Engineering highly preferred
• Lean Six Sigma Green Belt Certification or above preferred
• Knowledge of manufacturing processes, materials, product, and process design preferred
• Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques preferred
• Experience writing and executing validations preferred
• Experience in new product introduction or manufacturing engineering preferred
• Experience in an FDA regulated or regulated industry preferred

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.

To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.