Specialist, Engineering

Socket.dev; Durham (NC); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Annual bonus

Long‑term incentive

Comprehensive benefits

Job summary

Merck & Co., Inc. in Durham, NC is seeking a Technology Operations Specialist to lead vaccine process technologies, support drug substance and media development, and drive post-approval enhancements.

The role requires strong technical leadership, cross-functional collaboration, and excellent communication skills. You will participate in technology transfer, author critical technical documents, and assist in regulatory interactions while supporting on-shift coverage and continuous improvement

Qualifications

• Education: Bachelor's or Master's in a life sciences field with relevant experience.
• Experience in vaccine/biologics manufacturing within a cGMP environment.
• Ability to author technical documentation for regulatory filings including risk assessments.

Responsibilities

• Provide technical and team leadership for commercial technology transfer and qualification studies for vaccine processes.
• Lead cross-functional teams to advance projects, ensuring on-time delivery and compliance.
• Author/review technical documents and regulatory filings; support change control activities.
• Support regulatory inspections and respond to questions from multiple agencies (FDA/EMA).
• Mentor and coach junior staff, fostering a collaborative, growth-focused environment.

Skills

cGMP experience

Leadership

Technical writing

Project management

Cross-functional collaboration

Regulatory communication

Mentorship

Problem solving

Education

Bachelor's degree in Chemical Engineering/Biochemical Engineering/Bioengineering or related life science

Master of Science degree

Tools

SAP

MES

DeltaV

Job description

Job Description

Our Engineers support BCG operations, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

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 lifesaving vaccines in bulk and finished forms.

Durham’s Technology Operations Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology process knowledge, post approval support, and post commercial process enhancements activities for pipeline vaccine programs. This is position will support vaccine Drug Substance and Process Support and Media areas within the facility. .

Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

Responsibilities may include but are not limited to:

• Provide technical/team support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
• Provide deep SME knowledge for manufacturing investigations support (Product and process deviations and complex material-related)
• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments

• Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.

• Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls

• Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements

• Provide post approval support and subject matter expertise support to ongoing manufacturing activities.

Education Minimum Requirement:

• Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree.

Required Experience and Skills:

• Experience in vaccine or biologics manufacturing within a cGMP environment

• Experience authoring technical documentation within a cGMP context

• Proven leader with influence and outstanding communication (written & presentation) skills

• Experience with project 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:

• Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment

• Experience in manufacturing support processes including media development/manufacture and/or single-use component design and qualification

• Experience with technology transfer methodologies for introduction/launch of a cGMP product

• Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions

• Authored complex process change control

• Authored complex deviation investigations

• Experience with validation documentation and execution

• Experience with SAP

• Experience with Manufacturing Execution Systems (MES)

• Experience with Delta V

• Ability to provide scientific mentorship and guidance to technical colleagues

• Ability to read Piping and Instrumentation Diagrams

• Lean Six Sigma belt certification

• Experience with process risk assessment tools

• Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA)

• Experience with face to face presentation of technically complex subjects to regulatory inspectors

• Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals 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. #EBRG's #VetJobs

Required Skills:

Adaptability, Adaptability, Change Control Management, Change Control Processes, Change Controls, Chemical Engineering, Data Analysis, Deviation Investigations, Deviation Management, Equipment Troubleshooting, Good Manufacturing Practices (GMP), Lean Manufacturing, Legal Compliance, Manufacturing Execution Systems (MES), Manufacturing Systems, Personal Initiative, Process Design, Process Implementations, Process Improvements, Process Optimization, Process Verification, Professional Integrity, Project Implementations, Project Management, Regulatory Audits {+ 7 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:

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)

Cleaning Supplies

Job Posting End Date

09/23/2026

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.

Requisition ID

R417174

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