Supplier Project Engineer

cGxPServe; Acton (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in regulated industries is seeking a professional to lead supplier qualifications and collaboration across multiple functions. The ideal candidate will have a BS engineering degree, strong analytical and problem-solving abilities, and experience in FDA-regulated environments. Responsibilities include managing supplier capital qualifications and overseeing validation protocols.

Qualifications

• 3 years of relevant experience required.
• Experience in FDA regulated industry preferred.
• Six Sigma Process Improvement Certification desirable.

Responsibilities

• Manage supplier capital qualifications from kick-off to production implementation.
• Generate/review supplier validation protocols and coordinate their execution.
• Lead procurement and installation of manufacturing equipment.

Skills

Analytical skills

Problem-solving skills

Communication skills

Teamwork

Self-motivation

Education

BS Engineering Degree (Plastics, Mechanical, Manufacturing/Industrial)

Tools

SAS

JMP

Minitab

MS Office

Job description

Job Description:

• Strong written and verbal communication skills.
• Possess strong analytical and problem-solving skills.
• Familiarity with one of SAS, JMP, or Minitab is strongly desired.
• Working knowledge of MS Office, including Office Project software.
• Six Sigma Process Improvement Experience/Certification desirable.
• Regulated industry experience preferred.
• Familiarity with cGMP practices desired.
• Outstanding team player who seeks and values diverse input to hone ideas, but who has the experience to develop strong starting proposals.
• Highly motivated, self-starter.

Responsibilities:

• Lead, plan, manage and implement supplier capital qualifications from kick-off to implementation into production. Collaboration
• Generate or review supplier validation/qualification protocols and coordinate their execution and final reporting.
• Lead with teamwork and drive for results; able to work in a borderless organization and across multiple functions including, programs, engineering, purchasing and suppliers.
• Lead teams responsible for the procurement and installation of manufacturing equipment at global suppliers.
• All other duties as assigned.

Requirements:

• 3 years of relevant experience.
• BS Engineering Degree (Plastics, Mechanical, Manufacturing/Industrial) or related field.
• Ability to manage Supply Chain projects concept to production, including the authoring and oversight of IQ/OQ/PQ protocols for component manufacturing processes and secondary.
• Experience within an FDA regulated industry.
• Minitab is strongly desired or JMP.