Engineering, Specialist, Technical Operations Deviation Management

MSD; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Vacation

Sick leave

Hybrid work

Job summary

MSD in West Point, PA seeks an Incoming Materials Technical Operations specialist to provide on-site engineering support focused on deviation management. This role supports CAPA processes and regulatory readiness within Core Site Services.

You will collaborate with Operations, Quality, Planning, and vendors to investigate deviations, drive corrective actions, and lead continuous improvement initiatives in a GMP environment.

Qualifications

• Bachelor's degree in Engineering, Sciences, or related discipline.
• Minimum two years post-bachelor 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.
• Strong communication, leadership and teamwork skills.
• Ability to manage projects to schedule/deadlines.
• Strong technical writing skills.

Responsibilities

• Authors incident and investigation reports for deviations.
• Coordinates and completes CAPAs.
• Authors and reviews Incident Trend Reports.
• Supports deviation reduction efforts.
• Leads continuous improvement projects to increase compliance or reduce cost.
• On-the-floor support for project implementation and studies.

Skills

Deviation Management

CAPA coordination

Regulated environment experience

Technical writing

Project management

Education

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

Job description

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.

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.)

Required Skills

• 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}

US and Puerto Rico Residents Only:

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $87,300.00 - $137,400.00. 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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 10/7/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.