Freelance/Contract Senior/Principal Consultant - Sterility Assurance SME

Location: Sweden, with substantial site attendance and mainly office-based work in Uppsala. Candidates from the UK/EU who are willing to travel and work on site may also be considered.

Company

hirify.global provides regulatory, clinical, quality, compliance, pharmacovigilance, medical information, and R&D technology consulting solutions for biotech, medical device, and pharmaceutical organizations.

What you will do

• Provide expertise and leadership in sterility assurance and contamination control strategies.
• Support and lead aseptic processing activities and sterile manufacturing operations.
• Lead investigations involving deviations, OOS/OOT results, and other sterility-related issues.
• Review data, identify trends, and recommend areas for improvement.
• Review and approve contamination control documentation, risk assessments, SOPs, protocols, and reports.
• Support qualification, validation, audits, regulatory inspections, and quality risk management as a sterility SME.

Requirements

• BSc degree or higher in a life-sciences discipline.
• Extensive experience in the pharmaceutical or biotechnology sector.
• Advanced experience in sterility assurance within pharmaceutical or biotechnology environments.
• Ability to work mainly from the Uppsala office throughout the project.
• Fluent English required. Swedish is desirable.
• Strong problem-solving skills, experience supporting corrective procedures, and understanding of regulations required for compliance.

Nice to have

• Thorough experience with FDA regulations.
• Local contractor status in Sweden or the surrounding region.

Culture & Benefits

• Full-time project engagement for at least four months, with possible extensions.
• Independent consultant contract structure.
• Commitment to diversity, equity, inclusion, and equal opportunity.
• Recruitment applications are personally reviewed, with an outcome provided to every applicant.
• Remote work is supported company-wide, while in-person collaboration is encouraged where practical; this project requires substantial on-site attendance.

Hiring process

• Applications are reviewed personally by a member of the recruitment team.
• Applicants receive an outcome after the review.