Deviation Management Specialist - 36644 at Freyr

Position Details:

• Job ID: 36644
• Duration: 12 months (1/20/2025 – 1/20/2026)
• Benefits: Paid sick day, 401k, Discounted health insurance

Qualifications:

• Education Minimum Requirements:
• B.S. degree in Engineering or Sciences
• Required Experience and Skills:
• Minimum one (1) year of post-bachelor’s experience in GMP manufacturing and/or technical support of GMP operations (or an M.S. degree with <1 year experience)
• Demonstrated ability to meet assigned due dates
• Strong communication, collaboration skills, and ability to drive accountability
• Strong problem-solving skillset
• Preferred Experience and Skills:
• Vaccine manufacturing
• Sterile processing
• Experience authoring (investigations, reports, etc.)

Responsibilities:

• Manage deviations in support of vaccine production, including investigation initiation and closure
• Provide operations support, equipment troubleshooting, and process/equipment actions
• Develop technical expertise of process and product knowledge
• Collaborate with the Technical Operations Deviation Management team to ensure on-time closure of deviations
• Participate in root cause analysis, proposing and implementing effective corrective and preventive actions
• Write technical documents to support deviation closure using SAP
• Author/update technical and manufacturing documents needed for change control, process design, engineering studies, validation

Comments/Special Instructions:

• On-site position, Monday – Friday (with possible remote days, subject to business needs)
• Off-shift/weekend coverage may be required based on business unit needs
• Ideal candidate is comfortable collaborating across multiple teams and functions to identify and resolve deviations effectively

Regards,
Vinay Shastri
Senior Associate – Pharmaceutical Recruitment
Phone: +1 609 681 2410
Email: vinay.shastri@freyrsolutions.com
150 College Road West, Ste 102, Princeton NJ - 08540
www.freyrsolutions.com