Engineering, Specialist, Technical Operations Deviation Management

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! West Point Incoming Materials Technical Operations is seeking highly motivated individuals to provide on-site engineering technical support within manufacturing facilities at the West Point location.

The focus of the role includes Deviation Management, including Supplier, Incoming Materials and Environmental Monitoring Deviation investigations.

The Incoming Material Deviation Management Specialist is responsible for providing engineering/technical support to the Deviation Management Team within Core Site Services organization at West Point, PA site.

The specialist is responsible to support Incoming Material Integrated Product Technology area to remain operational, in compliance, continuously improve and innovate.

The Specialist:
Authors incident and investigation reports for deviations Coordinates and completes Corrective Actions and Preventive Actions (CAPAs) Authors and reviews Incident Trend Reports Supports deviation reduction efforts Supports, executes, and/or leads continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process. Examines complex issues from different perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

Authors, updates, and/or reviews and approves engineering, technical, and manufacturing documents (change control, validation documents, commissioning documents, etc.) necessary for engineering studies and project execution in a Good Manufacturing Practice environment. Provides on-the-floor support for project implementation and studies, as required Leads or participates in Quality Risk Assessments. Supports regulatory inspections/audits as required Supports team safety, environmental, and compliance objectives.

Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible. Collaborates effectively with Operations, Quality, Planning, project teams, and external vendors.

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

Minimum two (2) years post-bachelor’s degree experience in a regulated environment. Experience in deviation management / project support and/or change control and/or bio-pharm equipment and/or equipment/process validation. Highly developed communication, leadership and teamwork skills. Ability to manage projects/work to schedule/deadlines. Strong technical writing skills.

Experience in biologics, vaccine, or bulk sterile manufacturing facilities and equipment. Deviation Management Change Management Project Management Root Cause Analysis (Event and causal Factor, Causal Branching, etc.)

Adaptability, Adaptability, Business Writing, Causal Reasoning, Change Control Management, Change Controls, Competency Management, Continuous Improvement, Corrective Action Management, Data Analysis, Deviation Investigations, Deviation Management, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Personal Initiative, Process Optimization, Professional Integrity, Project Management, Project Team Management, Regulatory Compliance, Root Cause Analysis (RCA), Root Cause Identification, Root Cause Investigations, Schedule Adherence {+ 8 more}

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

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.

We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.

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