Senior Specialist, Engineering

Job Description Reporting to the Associate Director of PTO Engineering, the Senior Process/Project Engineer is responsible for providing technical support to Manufacturing Division-Wilson packaging operations (including oral solid dose and bottle packaging lines) as well as medical device assembly lines. This role involves planning, designing, and implementing technical projects while serving as a subject matter expert (SME) for assigned packaging lines and associated processes. The position requires strong technical expertise, project management capability, and knowledge of company standards, procedures, and practices. Key Responsibilities Specify, procure, install, and qualify new packaging and medical device assembly equipment. Provide ongoing technical support, performance monitoring, and troubleshooting for packaging and device assembly equipment. Partner with site and above-site teams to support the transfer of new products and processes from R&D or other manufacturing sites to Wilson. Project & Technical Leadership Independently or as part of a team, plan, design, and execute technical projects related to packaging and device assembly equipment and processes. Lead or contribute to project sub‑teams, ensuring effective communication and execution. Drive implementation of new technologies and applications of existing systems. Serve as the technical lead/SME for assigned packaging lines, providing recommendations and decision support. Process Support & Validation Support scale‑up and technology transfer of processes from pilot to commercial production, including: Equipment design and qualification Process demonstration and performance qualification Process validation (including packaging systems) Lead and support equipment qualification activities (IQ/OQ/PQ) and ensure adherence to validation standards. Author and maintain technical documentation, including process descriptions and change controls. Operations Support & Continuous Improvement Provide technical assistance to operations for equipment issues and in‑line product support. Lead root‑cause investigations and support resolution of equipment‑related quality events. Drive process improvements to enhance quality, efficiency, and productivity. Evaluate data, conduct experiments, and develop scientifically sound justifications for process changes. Quality & Compliance Support regulatory and quality activities, including site inspections, audits, and preparation of technical documentation (e.g., NDA supplements, FDA responses). Ensure all activities comply with company policies, site procedures, safety, and regulatory requirements. Maintain accurate and up‑to‑date process documentation and packaging process descriptions. Additional Responsibilities Review industry literature to identify new technologies and process improvements. Support evaluation of materials, specifications, and methods for packaging and device assembly. Provide technical guidance and training to less experienced team members. Education Requirements Bachelor's degree in Engineering or Industrial Technology (or related discipline) Required Experience & Skills Minimum of 5 years of relevant industrial experience Experience working in a GMP pharmaceutical environment Demonstrated leadership and teamwork skills Strong analytical and problem‑solving ability Excellent oral and written communication skills Ability to work effectively with limited supervision Strong mechanical aptitude with the ability to troubleshoot equipment issues Preferred Experience & Skills Experience in the pharmaceutical industry Experience with oral solid dose and bottle packaging systems Project management experience Experience with equipment qualification (IQ/OQ/PQ) Familiarity with Lean Six Sigma tools and methodologies Equal Employment Opportunity 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. Compensation and Benefits The salary range for this role is $117,000.00 - $184,200.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including 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. #J-18808-Ljbffr