Specialist, Engineering

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

Job summary

MSD in Durham, NC seeks a Technology Operations Specialist to support vaccine drug substance and media areas. Off-shift and weekend coverage may be required. You will lead tech transfer, document authoring for regulatory filings, and collaborate on continuous process improvements.

The role requires a Bachelor’s degree in a life science field and 2+ years of relevant experience in a cGMP environment. SAP/MES/DeltaV experience is preferred, with strong communication and project management skills.

Qualifications

• Experience in vaccine/biologics manufacturing in a cGMP environment.
• Experience authoring technical documentation within a cGMP context.
• Strong communication and leadership skills.

Responsibilities

• Provide technical leadership for tech transfer and qualification studies related to vaccine drug substance and components.
• Participate in cross-functional manufacturing teams to advance project goals.

Skills

GMP

Process Design

Project Management

Regulatory Audits

Education

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

Tools

SAP

MES

DeltaV

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

This 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

• 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

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 Management
• Process Improvements
• Process Optimization
• Process Verification
• Professional Integrity
• Project Implementations
• Project Management
• Regulatory Audits {+ 7 more}

Preferred Skills

• Risk Based Verification
• Systems Integration
• Advanced validation tools (IV&V)
• Professional certification (CDC, FDA, EMA OR

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.

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.

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

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.

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 and Other Details

• 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.

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