Deviation Management Specialist - I (Assistant)

TL;DR

Deviation Management Specialist - I (Assistant) (GMP Manufacturing): Technical support to vaccine manufacturing deviations with an accent on investigation initiation, root cause analysis, corrective/preventative actions, and product impact assessment. Focus on leading deviation investigations, supporting continuous improvement projects, and providing shop floor technical support.

Location: Site-based in West Point, PA (19486); M-F onsite required, two days remote per week may be available work permitting but not guaranteed. Off-shift or weekend coverage may be required.

Salary: $86,900

Company

Staffing agency providing connections in STEM fields for technical roles in manufacturing.

What you will do

• Lead or participate in deviation investigations to prevent recurrence, determine root cause, identify corrective/preventative actions, assess event scope and product impact.
• Examine issues from diverse perspectives including safety, compliance, automation, equipment, process, and people.
• Support continuous improvement projects to increase compliance, simplify processes, and gain efficiencies.
• Manage timelines for compliance and customer due dates, escalate risks, and develop remediation plans.
• Provide technical support to manufacturing shop floor for problems and issues.
• Author and update technical documents for investigations, process design, engineering studies, change control, and validation.

Requirements

• B.S. degree in Engineering or Sciences.
• Minimum 1+ year post-bachelor’s experience in GMP manufacturing or technical support (or M.S. with 0-1 year).
• Demonstrated ability to drive results to meet due dates.
• Strong communication, collaboration, and accountability skills.
• Strong problem-solving skills.

Nice to have

• Vaccine manufacturing experience.
• Sterile processing.
• Technical writing (investigations, protocols/reports).
• Investigative tools (5-whys, fishbone).
• Experience authoring investigations for atypical events in manufacturing.

Culture & Benefits

• For temporary assignments 13+ weeks: major medical, dental, vision, 401k, statutory sick pay where required.
• Reasonable accommodations for disabilities.
• Equal Opportunity Employer, participates in E-Verify.
• Considers qualified applicants regardless of criminal histories per fair chance laws.