Sterility Assurance Lead

Vaughan, ON
On-site
Posted Oct 15, 2026
1 position

US$140,000–US$170,000 / year

Applications are currently unavailable for this posting.

Employment type: Full-time
Experience level: Lead · 10+ years
Posting language: English
Working hours: 40 hours per week
Seniority: Mid-Senior level
Application method: Apply on LinkedIn (LinkedIn sign-in required)

Job summary

Provide subject matter expertise in sterility assurance, aseptic processing, and contamination control, translating EU GMP Annex 1 and other standards into practical technical requirements. Conduct gap and risk assessments, review project scopes and solutions, and collaborate with stakeholders to support implementation in existing pharmaceutical manufacturing facilities.

Job details

Our client is seeking an experienced Sterility Assurance Subject Matter Expert (SME) to support a major program and associated projects at its Illinois location. This is an opportunity for a seasoned pharmaceutical professional to apply their expertise in sterility assurance, aseptic processing and contamination control to support regulatory compliance and technical project execution. Key Responsibilities: Provide technical expertise in sterility assurance, aseptic processing and contamination control strategies. Interpret and translate EU GMP Annex 1 requirements, global standards and SOPs into practical, actionable technical requirements. Conduct and support gap assessments and risk assessments, identifying technical gaps and recommending solutions. Review project requirements, scope and proposed solutions to ensure alignment with sterility assurance and contamination control requirements. Collaborate with program stakeholders and project teams to support implementation within existing pharmaceutical manufacturing facilities. What We're Looking For: 10+ years of relevant experience preferred. Strong expertise in sterility assurance, aseptic processing, contamination control strategies and pharmaceutical manufacturing. Demonstrated knowledge of EU GMP Annex 1 and its practical application in existing manufacturing facilities. Experience with technical assessments, regulatory requirements and cross-functional project support. Compensation: $140K-$170K USD Disclosure: This posting represents an active and genuine vacancy with one of 3 Step Recruitment’s clients and is not for speculative or pipeline recruitment. 3 Step Recruitment and/or our Clients may use, from time to time, AI-assisted tools to support the screening and evaluation of applications; however, these tools are not intended to replace human judgement or decision-making in the hiring process.

What you’ll do

Requirements

The role prefers 10 or more years of relevant experience and strong expertise in sterility assurance, aseptic processing, contamination control, and pharmaceutical manufacturing. Candidates should understand the practical application of EU GMP Annex 1 in existing facilities and have experience with technical assessments, regulatory requirements, and cross-functional project support.