Engineering, Specialist, Technical Operations Deviation Management

MSD Malaysia; West Point (PA); Hybrid; USD 87,000 - 137,000; Full time

Job summary

West Point Incoming Materials Technical Operations is seeking individuals to provide on-site engineering support at the West Point, PA site. The role focuses on Deviation Management for Supplier, Incoming Materials, and Environmental Monitoring deviations, ensuring compliance and continuous improvement.

The specialist authors investigation reports, coordinates CAPAs, reviews incident trends, and supports regulatory activities, project timelines, and cross-functional collaboration to meet key due

Qualifications

• 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.

Responsibilities

• 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.

Skills

Adaptability

Communication

Project Management

Root Cause Analysis

Data Analysis

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.

Federal Contractor Statement

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.

Our Diversity Statement

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.

Salary

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.

Bonuses and Benefits

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.

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.

Application Deadline

The application deadline for this position is stated on this posting.

Employee Status, Relocation, etc.

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

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.