Specialist, Engineering (Onsite)
Merck
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Job summary
Merck seeks a Specialist Engineer to support sterile clinical manufacturing operations across multiple sites, starting in Durham, NC, then relocating to Rahway, NJ. The role covers formulation, filling, lyophilization, and validation activities with emphasis on GMP compliance and operational readiness.
The position requires hands-on technical skills across equipment, automation, and process development, with travel between sites and a focus on delivering high-quality clinical drug products on
Qualifications
- B.S. degree in chemical/ bio-chemical engineering, chemistry, or related sciences with at least 2 years of relevant experience.
- Familiarity with US and EU GMP and safety regulations.
- Strong problem-solving, organization, and cross-functional collaboration skills.
- Excellent verbal and written communication skills.
Responsibilities
- Serve as technical SME for formulation, process development, and scale-up activities.
- Support Quality Engineering and capital projects including equipment installation, commissioning, validation, and lifecycle management.
- Lead sterilization and cleaning validation programs via validation documents and regulatory support.
- Own change management, deviation investigations, root cause analyses, and CAPA implementation.
- Maintain GMP compliant facilities, utilities, and equipment using reliability maintenance.
- Manage work orders, budgets, asset tracking, and project closeout activities.
Skills
Education
Job description
The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile 2 facility expansion is a strategic capital project designed to significantly enhance clinical supply manufacturing capacity by adding a second sterile filling and lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure and utilities. The Durham, North Carolina site is a commercial vaccine manufacturing facility with drug substance, drug product, and sterile supply manufacturing operations, and supporting infrastructure and utilities.
The Specialist Engineer position will initially be based in Durham, NC for approximately 12 to 18 months to support business needs. After completion of this initial 12-to-18-month period, the role will relocate to Rahway, NJ based on business needs. This location change will not be considered a “termination of employment due to a restructuring” as defined in the company's US Employee Separation Benefit Plan. The role will require on-site support.
The 12 to 18 month rotation at the Durham, NC site will allow the Specialist Engineer to gain experience supporting commercial drug product manufacturing operations including formulation, filling, lyophilization, and visual inspection. Responsibilities at the Durham site will be based on business needs and may include but are not limited to shop floor equipment and automation troubleshooting, deviation investigation support, change controls, equipment validation, technical protocol authoring and execution, and equipment maintenance.
FLEx 2 is a strategic expansion that will increase sterile clinical manufacturing capacity through additional filling, lyophilization, formulation, and supporting utility suites. These roles provide technical support across formulation, process development, manufacturing, equipment, and automation to ensure GMP compliance, operational readiness, and efficient, reliable sterile drug product operations.
- Serve as technical SME for formulation, process development, and scale-up activities.
- Support manufacturing by authoring quality investigations, change controls, SOPs, and technical protocols required to support clinical drug product operations.
- Contribute the execution of the commissioning, qualification, and regulatory certification of the FLEx Sterile GMP Clinical Manufacturing facility.
- Collaborate closely with the formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline.
- Work with a variety of state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment while completing processes throughout the manufacturing cycle.
- Manage individual project assignments and aid in facility and process equipment innovation.
- Perform manual and/or automated operations, general maintenance, troubleshooting and support functions.
- Serve as a technical SME for equipment troubleshooting, maintenance, and coordination with engineering, utilities, facilities, OEM vendors, and contractors.
- Support Quality Engineering and capital projects, including equipment installation, commissioning, validation, and lifecycle management.
- Lead sterilization and cleaning validation programs by authoring and reviewing validation documents, coordinating execution activities, conducting technical assessments, and supporting regulatory inspections as a validation SME.
- Own change management, periodic reviews, deviation investigations, root cause analyses, and CAPA implementation while maintaining GMP documentation.
- Maintain GMP compliant facilities, utilities, and manufacturing equipment using reliability maintenance practices, tracking calibrations and PMs, and assisting with shutdown planning and execution.
- Manage operational and administrative activities including work order oversight, contractor coordination, purchase orders, budgets, asset tracking, and project closeout activities.
- Maintain validated and compliant automation systems for sterile manufacturing, ensuring adherence to GMP, data integrity, cybersecurity, and lifecycle management requirements.
- Provide automation support for formulation, filling, and lyophilization operations, including troubleshooting, root cause analysis, reliability improvements, and on‑floor manufacturing support.
- Lead automation change management, investigations, CAPAs, periodic reviews, and regulatory inspection readiness while maintaining automation documentation and system configurations.
- Support capital projects and new product introductions by leading automation design, integration, FAT/SAT, commissioning, qualification (AIOQ), and acceptance testing activities.
- Manage automation system strategy and lifecycle planning, including upgrades, expansions, obsolescence remediation, OT/IT architecture, cybersecurity, backups, and disaster recovery.
- Develop data, reporting, and visualization solutions while collaborating with manufacturing, quality, facilities, engineering, IT, and external vendors to drive operational excellence and continuous improvement.
- B.S. Degree in Chemical/Bio-Chemical Engineering or Chemistry/Biological Sciences or related disciplines. with a minimum of 2 years of relevant experience.
- Familiarity with United States and European Union GMP and safety compliance regulations.
- Strong problem‑solving skills and ability to work independently.
- Strong organizational skills with the ability to manage multiple priorities and deadlines.
- Ability to collaborate effectively with cross-functional teams and stakeholders.
- Excellent verbal and written communication skills.
- Project management
- Cross functional leadership
- Change Control
- Deviation Management
- Strong technical writing
- Sterile process manufacturing, sterile drug product and/or formulation development
- Electronic Batch Records
- Equipment Maintenance
- Operation Maintenance
- Pilot Plant Operations
- Process Engineering
- Process Manufacturing
- Product Formulation
- Root Cause Identification
- Sterile Manufacturing
- Troubleshooting
- Clinical Manufacturing
- Drug Product Manufacturing
- Manufacturing Operations
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
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.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
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.
Regular
Domestic
No
10%
Not Applicable
1st - Day, 2nd - Evening
No
n/a
09/26/2026
$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.
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 successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
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