Senior Specialist, Engineering

Merck•Wilson, NC

6d•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. Responsible for specifying, purchasing, installing, and qualifying new packaging and device assembly equipment. Also responsible for packaging and device assembly equipment performance, support, and troubleshooting for products packaged at our Manufacturing Division-Wilson. Works closely with Wilson and above-site departments for the transfer of new products and processes from our Research & Development Division or other Manufacturing Division sites to our Manufacturing Division -Wilson. The basic function of this position is to, independently or as part of a project team, plan, design and implement technical projects related to packaging and medical device equipment/processes. Work requires a strong technical background and project management skills, as well as working knowledge of our company's methods, standards, procedure, and practices. Experience in equipment installation and qualification for complex systems. This position requires the engineer to be the technical subject matter expert for the assigned packaging lines and to make recommendations for decisions associated with these lines and their associated products. Utilizes strong communication skills to lead project sub teams or be a key contributor on site and above-site sub teams. Leads implementation of new technology and new applications of existing technology. The Senior Process/Project Engineer is expected to collect and interpret information, to develop solutions and to make decisions with high liability to projects of varying scopes. Expertise in qualification and process validation practices for complex systems is essential to success in this role. Very minimal supervision, guidance, and direction are employed by the Associate Director; however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort. The Senior Process/Project Engineer will also provide leadership and training to others.

Requirements

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.

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. 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.