Merck · 1 week ago
Senior Specialist, Engineering
Wilson, NC
Full-time
Hybrid
Senior Level
$115K/yr - $180K/yr
5+ years expMerck is a leading pharmaceutical company, and they are seeking a Senior Specialist in Engineering. The role involves providing technical support for packaging and medical device assembly lines, managing projects for equipment installation and qualification, and ensuring compliance with quality and regulatory standards.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Responsible for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing site at Wilson. This includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation
Responsible for managing capital and expense projects for installation and qualification of new packaging and medical device assembly equipment and modifications/optimizations to existing equipment
Provides technical assistance to packaging operations in the resolution of packaging and device assembly 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 Packaging Process Descriptions. This requires a thorough knowledge of the packaging 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 Wilson site procedure for safety, quality, and regulatory compliance
Review literature pertaining to pharmaceutical packaging in order to introduce new profitable/productivity ideas into the packaging operation
Provides technical support in critically evaluating quality standard specifications and methods for raw materials and intermediate and final products
Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified packaging components and Medical Device and Combination products
Technical support for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing Division -Wilson. This includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation
Responsible for authoring process change controls and completing tasks to implement packaging and device assembly equipment/process changes
Provides technical assistance for quality and regulatory activities including site inspections and preparation of technical documents for FDA observation
Qualification
Required
Bachelor of Science in Engineering or related field
Minimum of 5 years relevant industrial experience
Experience working in a GMP Pharmaceutical Environment
Demonstrated leadership and teamwork skills
Excellent analytical ability
Proven communication skills. Strong oral and written communication skills
The ability to work under limited supervision
Mechanical aptitude to troubleshoot/resolve equipment issues
Preferred
Experience in pharmaceutical industry
Experience in Medical Devices and Combination products
Project management skills
Experience in equipment qualification activities
Experience in the use of Lean Six Sigma tools
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-21
2026-01-20
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