Specialist Engineering

Merck; Durham (NC); On-site; USD 87,000 - 137,000; Full time

Job summary

Merck in Durham, NC seeks a Growth and Improvement-minded Specialist, Engineering to drive strategic priorities within Technical Operations. You will collect data, develop solutions, and exercise independent judgment on projects of varying scope.

Responsibilities include root cause analysis for thawing/pooling/filling equipment, documenting process changes, and supporting QA/regulatory activities. A BS in Engineering with 2 years in pharma is required.

Qualifications

• BS in Engineering or related field with 2 years in pharma ops/technical services/quality operations.
• 2+ years of relevant industrial experience.
• Experience in GMP pharmaceutical environments.

Responsibilities

• Provide technical assistance to thawing/pooling/filling equipment for in-line products; lead root cause investigations.
• Write scientific justification for proposed changes; design experiments and review data.
• Support QA/regulatory activities, site inspections, NDA supplements, and environmental issues.
• Ensure accuracy of Process Descriptions and CP Memos with in-depth process knowledge.
• Complete process eng/ development tasks per safety, quality, and regulatory policies.
• Review literature on aseptic filling/lyophilization to drive improvements.
• Support design, machinability evaluation, and qualification of new or modified equipment components.
• Provide on-shift support during critical runs (Aseptic Process Simulation, protocol execution).
• Author process change controls and implement equipment/process changes.

Skills

Root cause analysis

Technical troubleshooting

Data interpretation

Written communication

Cross-functional collaboration

Education

BS in Engineering

Tools

Process equipment

Job description

Job Description

We are seeking a Growth and Improvement-minded Specialist, Engineering that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs.
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business).
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape.
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world.
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges.

The Specialist, Engineering will serve as a member of the Technical Operations team supporting thaw, pool, and filling manufacturing areas. The Specialist, Engineering is expected to collect and interpret information, to develop solutions and to make decisions with high liability to projects of varying scopes. Very minimal supervision, guidance, and direction are employed by the Associate Director, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.

Primary Responsibilities

• Provides technical assistance to manufacturing operations in the resolution of thawing/pooling/filling equipment problems for in-line products. This involves leading root cause analysis investigations for equipment-related quality events.
• Provides written scientific justification for proposed changes by conducting literature search, designing and executing experiments, analytically reviewing current and past data, and demonstrating the impact of process changes on product quality, production efficiency, or productivity.
• Provides technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues.
• Responsible for the accuracy of Process Descriptions and Critical Process Parameter Memos. This requires a thorough knowledge of the Drug Product operations, the hazards involved, and the in-process controls necessary to obtain reproducible results.
• Responsible for completing all process engineering/process development activities with the highest regard for all of our Company Divisional policies and Durham site procedure for safety, quality, and regulatory compliance.
• Review literature pertaining to pharmaceutical aseptic filling and lyophilization in order to introduce new profitable/productivity ideas into the Drug Product operation.
• Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified equipment components
• Supports on shift support during critical manufacturing runs such as Aseptic Process Simulation, protocol execution, and developmental runs
• Responsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes.

Education Minimum Requirement

• Bachelor of Science Degree (BS) in Engineering or related fields with two (2) years’ experience in pharmaceutical operations, technical services, or quality operations;

Required Experience And Skills

• Minimum of 2 years relevant industrial experience.
• Experience working in a GMP Pharmaceutical Environment.
• Demonstrated leadership and teamwork skills.
• Proven communication skills. Strong oral and written communication skills.
• Mechanical aptitude to troubleshoot/resolve equipment issues.

Preferred Experience And Skills

• Experience in deviation management and/or change control and/or equipment support and/or project support role.
• Experience in pharmaceutical industry.
• Project management skills.
• Experience in writing process change controls.
• Experience in the use of Lean Six Sigma tools. #EBRG's #VetJobs

Required Skills

Adaptability, Adaptability, Change Control Management, Change Controls, Collaborative Leadership, Competency Management, Data Analysis, Equipment Designing, Equipment Troubleshooting, Evaluate Information, Good Manufacturing Practices (GMP), Leadership Theories, Lean Manufacturing, Operations Engineering, Organizational Leadership, Personal Initiative, Procedure Writing, Process Definition, Process Optimization, Product Analysis, Professional Integrity, Project Implementations, Project Leadership, Project Management, Project Scoping {+ 9 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.

Requirements

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:

EEOC Know Your Rights

EEOC GINA Supplement

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

NA

Job Posting End Date

10/21/2026

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.

Additional location(s) Compensation Information:

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

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

The salary range for the primary location of this role is:

$87,300.00 - $137,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Requisition ID: R422184