Lead Contract Packaging Project Engineer – Scale-Up

Sterimed Infection Control; South Carolina; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

International training at Riverside Medical (UK)

Paid Life Insurance – $50k coverage

Health/Dental insurance benefits

401k with 100% employer match

Job summary

Sterimed Infection Control in Ridgeville, South Carolina is seeking a high-impact Project Engineer to lead the technical establishment of new Contract Packaging activities. This growth-oriented role will act as the technical bridge among various teams and direct the conversion of customer opportunities into operational programs.

The candidate should have a Bachelor’s degree in relevant engineering fields and over 4 years of experience in medical device manufacturing. Key responsibilities include managing project plans, authoring SOPs, and ensuring compliance with FDA and ISO standards.

Qualifications

• 4+ years of experience in medical device manufacturing, contract packaging, or regulated manufacturing environments.
• Proven experience in validation (IQ/OQ/PQ) and SOP development.
• Strong working knowledge of FDA QSR and cGMP standards.

Responsibilities

• Lead the transfer of contract packaging processes to Ridgeville, SC.
• Author and implement SOPs and validation documentation.
• Act as technical project lead for new customer programs.

Skills

Mechanical Engineering

Manufacturing Engineering

Validation (IQ/OQ/PQ)

SOP Development

ISO 13485

cGMP

Project Management

Lean

Six Sigma

Education

Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Packaging Engineering

Job description

Sterimed Infection Control in Ridgeville, South Carolina is seeking a high-impact Project Engineer to lead the technical establishment of new Contract Packaging activities. This growth-oriented role will act as the technical bridge among various teams and direct the conversion of customer opportunities into operational programs.

The candidate should have a Bachelor’s degree in relevant engineering fields and over 4 years of experience in medical device manufacturing. Key responsibilities include managing project plans, authoring SOPs, and ensuring compliance with FDA and ISO standards.