Specialist, Engineering

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation days

Sick days

Job summary

Merck's Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, NC is seeking a PSL Specialist to lead key projects in Vaccines Manufacturing support, including study execution, data analysis, documentation, and cross-functional coordination.

You will work with Manufacturing, Quality, and Technical Operations, apply aseptic practices, cell culture processing, and cGMP documentation, and occasionally support off-shift or weekend assignments to meet project needs.

Qualifications

• Bachelor's degree in Engineering or Science and 2+ years of relevant experience, or Master's/PhD with relevant experience.
• Experience in vaccine or biologics processing, analytics.
• Experience authoring technical documentation in a cGMP context.
• Strong written and verbal communication skills.
• Strategic plan development and management.
• Ability to mentor and develop SMEs.

Responsibilities

• Manage PSL projects: scope, planning, execution, documentation, stakeholder communication.
• Contribute to laboratory studies supporting investigations, transfers, and process improvements.
• Author/review experimental designs, protocols, reports, data summaries and updates.
• Apply understanding of vaccine manufacturing processes (upstream, cell culture, downstream, drug product, analytics).
• Operate or support analytical equipment for in-process/post-process testing and troubleshooting.
• Execute studies for developmental or continuous improvement projects.
• Support cell culture activities including preparation, monitoring, data review.
• Participate on cross-functional teams to advance project goals.
• Provide SME knowledge for manufacturing investigations.

Skills

Project management

Technical communication

Data analysis

Cross-functional collaboration

Aseptic handling

Laboratory instrumentation

Education

Bachelor's degree in Engineering or Science

Master's degree in Engineering or Science

Tools

cGMP documentation

Laboratory analytics equipment

DOE/OFAT thinking

Job description

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state‑of‑the‑art facility established in 2004 manufactures our Company's lifesaving vaccines in bulk and finished forms.

The Process Support Lab at the Durham site is seeking a Specialist with strong technical, interpersonal, communication, and collaboration skills. The PSL Specialist will be responsible for managing key projects related to Vaccines Manufacturing support, including laboratory study execution, project planning, data analysis, technical documentation, and cross-functional coordination. This role will support manufacturing investigations, process monitoring, technical transfer activities, and continuous improvement efforts for Durham vaccine products and pipeline programs. The successful candidate will be a hands‑on technical contributor with familiarity in laboratory analytical equipment, cell culture processing, aseptic practices, and cGMP documentation expectations. To be successful in this role, the candidate must be able to manage multiple priorities in a fast-paced environment while partnering effectively with Manufacturing, Quality, Technical Operations, and laboratory teams.

The candidate will be required to work in a fast-paced environment. Off-shift or weekend coverage will occasionally be needed to assist the technical team, based on project‑specific assignments and/or the vaccine production schedule.

Primary Duties

• Manage key PSL projects related to Vaccines Manufacturing support, including project scope, planning, execution, documentation, and stakeholder communication.
• Serve as a technical contributor for laboratory studies supporting manufacturing investigations, process monitoring, technical transfer, and process improvement activities.
• Author and review experimental design proposals, laboratory protocols, technical reports, data summaries, and project updates in alignment with cGMP expectations.
• Apply technical understanding of vaccine manufacturing processes, including upstream processing, cell culture operations, downstream processing, drug product support, and laboratory analytics.
• Operate, coordinate, or support laboratory analytical equipment used for in-process, post-process, and investigational sample testing, including method execution, troubleshooting, and equipment readiness activities.
• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.
• Support cell culture processing activities, including preparation, execution, monitoring, sampling, data review, and troubleshooting in laboratory or manufacturing‑support settings.
• Actively participate on cross‑functional teams to advance project goals and deliverables related to vaccine processes or analytics.
• Provide SME knowledge for manufacturing investigations (Product, process, and testing deviations).

Required Education, Experience And Skills

• Bachelor's degree in Engineering or Science AND a minimum of two (2) years of relevant experience OR Master's degree in Engineering or Science OR Ph.D. with relevant academic experience
• Experience in vaccine or biologics processing, including either lab- or manufacturing- scale support in analytics.
• Experience authoring technical documentation within a cGMP context
• Proven technical communication (written & presentation) skills.
• Strategic plan development and management
• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

Preferred Experience And Skills

• Vaccine or biologics manufacturing within an aseptic, cGMP environment
• cGMP manufacturing or Quality Operations support including providing immediate responses on the shop floor to deviations and potential deviations
• Ability to drive studies and experiments in the context of a long‑term commercialization plan
• Design of Experiment (DOE) and One Factor at a Time (OFAT) experimental design
• Experience authoring technical documents supporting regulatory filings (IND, BLA).
• Experience using digital visualization tools (PowerBI, JMP, etc.)
• Ability to provide scientific mentorship and guidance to technical colleagues
• Prior experience performing analytical assays (i.e. potency assays, serial dilutions, moisture testing, SDS-Page, dry weight, UV-Vis, BCA Assay)
• Prior experience with any of the following equipment ex: SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers etc.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time. #VetJobs #EBRG's

Required Skills

Adaptability, Adaptability, Analytical Instrumentation, Aseptic Handling, Biologics, Culture Media, Data Analysis, Design of Experiments (DOE), Downstream Processing, Equipment Troubleshooting, Experimental Methods, Good Manufacturing Practices (GMP), Laboratory Instrumentation, Lean Manufacturing, Perform Testing, Personal Initiative, Process Optimization, Process Testing, Professional Integrity, Project Management, Regulatory Submissions, Root Cause Analysis (RCA), Sample Testing, Scientific Research, Technical Presentations {+ 5 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.

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

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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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)

N/A

Job Posting End Date

10/1/2026

Job Posting Validity

• 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.

Requisition ID

R419405

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.

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.

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