Engineering, Specialist, Technical Operations Deviation Management

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.

Education Minimum Requirement: 

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

Required Experience and Skills:

• 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

Preferred Experience and 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.)

Current Employees apply HERE

Current Contingent Workers apply HERE

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

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.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.