Specialist Engineering - Incoming Materials

Job Description

Our company aspires to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and use the power of leading-edge science to save and improve lives around the world.

West Point, PA Technical Operations for the Incoming Materials (IM) team is seeking a highly motivated individual for a Specialist, Engineering position. The successful candidate will partner with Suppliers, IM Quality, Planning, Procurement, Validation, Warehouse, Supplies Inspection, Global IM Tech Ops, Supplier Development & Performance Development, and Supplier Quality Management to ensure that the incoming materials used across the West Point site support the manufacture of the highest quality vaccines.

• Execute change management for supplier-initiated changes and site-initiated incoming material projects.
• Author and update GMP technical documents and SOPs to support incoming material qualification and change control.
• Design and conduct experimental protocols to support incoming material qualification, testing, and improvement projects.
• Provide technical support for Warehouse, Supplies Inspection, and incoming materials used in manufacturing areas across the West Point site.
• Lead or support execution of Quality Risk Assessments.
• Support regulatory inspection activities for the facility.
• Support IM Deviation Management team investigations and Corrective/Preventative Actions (CAPAs) if necessary. Improve Right-First-Time performance and prevent/reduce deviations.
• Support and/or execute continuous improvement projects to increase compliance, simplify/standardize processes, resolve release issues, and gain efficiencies.
• Manage project timelines to ensure key compliance and customer due dates are met; escal…
• Support team safety, environmental, and compliance objectives.

Required

• Bachelor’s Degree or higher (Engineering or Sciences, preferred)
• Minimum two (2) years post-bachelor’s degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.
• Experience in change control and/or project support role.
• Highly developed communication, leadership, and teamwork skills.
• Ability to manage projects/work to schedule/deadlines.

Preferred

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
• Change Control author
• Supplier Change Notification experience
• Project Management
• Technical Writing

Adaptability, Biopharmaceutical Industry, Biopharmaceutical Operations, Biopharmaceutics, Change Controls, Change Management, Continuous Improvement Projects, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, GMP Compliance, Improvement Projects, Process Optimization, Professional Engineering, Project Management, Quality Risk Assessment, Software Proficiency, Supplier Quality Management, Teamwork, Technical Communication, Technical Problem-Solving

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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.

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