Senior Process / Project Engineer-2

Merck • Wilson, NC

7d • Hybrid

About The Position

Reporting to the Associate Director of PTO Engineering, the Senior Process/Project Engineer is responsible for providing technical support of our Manufacturing Division-Wilson packaging and medical device assembly lines. This role involves specifying, purchasing, installing, and qualifying new packaging and device assembly equipment, as well as supporting and troubleshooting existing equipment performance. The engineer will collaborate with Wilson and above-site departments for the transfer of new products and processes. The position requires a strong technical background, project management skills, and a working knowledge of company methods and standards. The engineer will act as the technical subject matter expert for assigned packaging lines, leading project sub-teams and driving the implementation of new technology. Expertise in qualification and process validation for complex systems is essential, with minimal supervision required. The role also involves providing leadership and training to others.

Requirements

• Bachelor's degree in engineering, Industry Technology, Mechanical Engineering, Chemical Engineering or related.
• 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.
• Adaptability
• Analytical Testing
• Conducting Experiments
• Data Analysis
• Detail-Oriented
• Deviation Management
• Engineering Processes
• Equipment Qualification
• Experimental Methods
• Good Manufacturing Practices (GMP)
• Leadership
• Literature Reviews
• Mechanical Troubleshooting
• Medical Devices
• Packaging Processes
• Pharmaceutical Packaging
• Process Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Quality Evaluation
• Regulatory Compliance
• Root Cause Analysis (RCA)
• Strategic Thinking
• Technical Leadership

Nice To Haves

• 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.

Responsibilities

• Responsible for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing site at Wilson, including 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, including 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, requiring a thorough knowledge of packaging operations, hazards, and necessary in-process controls.
• Responsible for completing all process engineering/process development activities with the highest regard for all Company Divisional policies and Wilson site procedures 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.
• 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.

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
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior