Pharma Investigator - PI 25-22758

Job Title: Pharma Investigator

Location: West Point, PA

Duration: 12 Months (Contract)

Education Requirements:

• B.S. or B.A. in Engineering, Sciences, or a related discipline

• 2–4 years of relevant experience (co-op/internship experience acceptable in combination with full-time roles)

Required Experience and Skills:

• Strong technical writing abilities

• Excellent verbal and written communication skills

• Strong leadership and collaboration skills

• Proven ability to manage multiple projects and meet deadlines

Preferred Experience and Skills:

• Experience in biologics, vaccine, or bulk sterile manufacturing environments

• Familiarity with Change Control processes

• Experience with Deviation Management and Investigations

• Author, update, and lead GMP documentation such as SOPs, batch records, technical protocols, validation documents, and change control documents

• Support deviation investigations including impact assessments, root cause analysis, and development of corrective and preventive actions (CAPAs)

• Assist in writing investigations and quality incident reports

• Provide support for facility, equipment, and continuous improvement projects across sterile supply departments

• Analyze complex issues from a broad perspective (compliance, equipment, safety, process, automation, personnel) to identify and resolve root causes

• Design and review experimental protocols where needed

• Deliver hands-on, floor-level support for resolving technical or operational challenges

• Lead or contribute to performance improvement projects to enhance compliance, reduce costs, increase efficiency, or improve Right-First-Time performance

• Actively support environmental, safety, and compliance goals

• Manage project timelines, escalate risks to deliverables, and develop mitigation plans

• Collaborate closely with cross-functional teams, including Quality, Operations, Planning, Engineering, and external partners