Freelance/Contract Senior/Principal Consultant - Sterility Assurance SME

Location: Sweden; mainly office-based with substantial site attendance in Uppsala throughout the project. Local contractors in Sweden are preferred, while candidates from the UK/EU who can travel and work onsite are considered.

Company

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

What you will do

• Provide leadership and subject-matter expertise in sterility assurance and contamination control strategies.
• Support and lead aseptic processing activities, sterile manufacturing qualification, and validation.
• Lead sterility-related investigations, including deviations, OOS/OOT results, and corrective procedures.
• Review data, identify trends and improvement areas, and approve contamination control documentation and risk assessments.
• Provide technical guidance on cleanroom operations, gowning qualification, and aseptic behaviors.
• Act as a sterility SME during regulatory inspections, client and internal audits, and contribute to SOPs, protocols, and reports.

Requirements

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

Nice to have

• Thorough experience with FDA regulations.
• Swedish language skills.

Culture & Benefits

• Full-time project engagement for at least 3–4 months, with possible extensions.
• Independent consultant engagement with a full-time project commitment, or as close as possible.
• Collaborative, inclusive, and entrepreneurial working environment.
• hirify.global supports remote working generally but encourages in-person collaboration and hybrid office work for eligible hires; this project specifically requires substantial onsite attendance.
• Applications are personally reviewed by the recruitment team without AI screening, and applicants receive an outcome.

Hiring process

• Apply directly; hirify.global does not accept unsolicited resumes from recruiters or third parties.
• Do not contact anyone by phone or email regarding this posting.