Sr. Specialist, Engineering - Raw Material Planner; Onsite
Listed on 2026-06-25
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Location: West Point
Job Description
Applications are sought for a Raw Material Planner Sr. Specialist within Planning and Manufacturing Systems (PAMS) in our Company's Research & Development Bioprocess Clinical Manufacturing and Technology (BCMT). The individual will support pilot‑scale campaigns for the GMP manufacture of bulk biologics (vaccines, therapeutic proteins, monoclonal antibodies) clinical supplies.
Responsibilities- Establish priorities for raw material (RM) procurement and procure RM internally or externally (outside vendors).
- Coordinate culture media (CM)/buffer manufacturing.
- Collaborate across the network (internal and external) to benchmark, understand, influence, and execute standards of RM management.
- Coordinate RM/CM deliveries to and from Biological Support Operations (BSO) and to Process Research and Development (PR&D) bulk manufacturing suites, including the Biologics Pilot Plant (BPP).
- Track and manage inventory of RMs and GMP supplies, including single‑use technology.
- Manage RM/CM storage space.
- Collaborate with the Process Development team to determine critical parameters.
- Perform CM laboratory studies as determined.
- Participate in SOP development, support of new IT initiatives, and supply‑chain management of RMs and GMP supplies.
Excellent understanding of the regulatory guidelines governing GMP manufacture is required.
RequiredEducation and Experience
- BS degree in Engineering, Sciences, Business, or a related field with a minimum of 5 years of relevant experience, or a master’s degree with a minimum of 3 years of relevant experience.
- Ability and desire to work in a fast‑paced, dynamic pilot‑plant environment that demands out‑of‑box thinking, prioritization, and rapid response to events and situations.
- Direct experience with SAP/PASX.
- Strong understanding of manufacturing principles/processes through work experience.
- Ability to work collaboratively as part of a team across various functions in a challenging and changing global environment.
- Proven track record of analytical skills, problem‑solving, and attention to detail.
- High personal integrity, credibility, and energy.
- Strong written and verbal communication skills.
- Strong computer skills in Excel.
- Experience in pharma/sterile manufacturing.
- Adaptability
- Analytical Testing
- Data Analysis
- Detail‑Oriented
- Deviation Management
- Equipment Qualification
- Good Manufacturing Practices (GMP)
- Process Design
- Process Hazard Analysis (PHA)
- Process Optimization
- Root Cause Analysis (RCA)
- Strategic Thinking
- Technical Leadership
- Technical Problem‑Solving
- Technical Writing
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
SalaryRange
$ – $
BenefitsThe successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance for the employee and family, retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days.
Shift1st – Day
Travel RequirementsNo Travel Required
RelocationDomestic
Visa SponsorshipNo
Job Posting End Date06/24/2026
Eligible LocationsUS and Puerto Rico residents only. San Francisco and Los Angeles residents only: compliance with respective fair‑chance ordinances.
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