[ref. c5629522] Assistant Deviation Management Specialist - ADMS0102#AT01

Duration: 12 Months

Schedule: Onsite M-F, with potential for up to 2 remote workdays per week (not guaranteed). Off-shift or weekend coverage may be required based on business needs.

Overview:

The role involves technical expertise in process and product knowledge, as well as cross-functional collaboration to address equipment, process, and operational challenges.

Responsibilities:

• Lead or collaborate on manufacturing investigations and process improvement projects.
• Analyze issues from multiple perspectives (safety, compliance, automation, equipment, process, and people) to identify root causes and propose effective corrective and preventative actions (CAPAs).
• Ensure consistent application of standardized work, engineering, and process tools.
• Provide technical support for manufacturing operations and equipment troubleshooting.
• Design and conduct experimental protocols using lab facilities or production equipment at full scale.
• Write and close technical documents and deviations using the SAP system.
• Author and update technical and manufacturing documents for investigations, process design/definition, engineering studies, process demonstrations, change control, and validation.

Qualifications:

Education:

• Minimum: B.S. degree in Engineering or Sciences.

Required Experience and Skills:

• At least 1 year of post-bachelor's degree experience in GMP manufacturing or technical support of GMP operations. (M.S. degree with less than 1 year of experience is acceptable.)
• Proven ability to meet deadlines and deliver results.
• Strong communication and collaboration skills, with a focus on driving accountability.
• Demonstrated problem-solving capabilities.

Preferred Experience and Skills:

• Experience in vaccine manufacturing or sterile processing.
• Familiarity with authoring technical documents.

Additional Notes:

This site-based role is critical to the success of vaccine production operations and requires a proactive, detail-oriented individual with strong technical and problem-solving skills.