Senior Process Engineer - NPI & GMP Manufacturing

Randstad USA

Tempe (AZ)

On-site

USD 76,000 - 85,000

Full time

2 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

AD&D insurance

Life insurance

Short-term disability

401K plan

Job summary

Randstad USA is seeking a Senior Process Engineer, Advanced Operations in Tempe, AZ. The role focuses on leading new product introductions and driving manufacturing innovation within a sustainability-driven, industry-leading organization.

Requires a Bachelor's in Engineering and 2+ years of related experience, with background in FDA-regulated environments and knowledge of DFM, statistical tools, and Lean Six Sigma principles. Contract position with comprehensive benefits offered.

Qualifications

Bachelor's degree in Engineering required with 2+ years of relevant experience.
Experience in new product introduction, manufacturing engineering, and validations within an FDA-regulated industry.
Knowledge of manufacturing processes, DFM, statistical tools, and Lean Six Sigma (Green Belt or above preferred).

Responsibilities

Provide hands-on engineering support for NPI, ensuring processes and documentation align with development procedures.
Oversee equipment selection, design, capital acquisition, contract negotiation, installation, and validation.
Generate operating manuals, capability studies, inspection documentation, and MSA studies.
Participate in PFMEA, control plans, SOPs, and PPAP generation for launches and transfers.
Ensure adherence to GMP, safety, FDA standards, deadlines, and cost targets.