Packaging Technical Operations - Specialist-Engineering

Reporting to the Associate Director of PTO Engineering, the Specialist, Technical Operations Engineer provides technical support for the packaging and medical device assembly lines at the Manufacturing Division Wilson site.

About the role

This role is responsible for equipment performance through providing on-site support and troubleshooting of packaging and device assembly operations. The Specialist works closely with Wilson and above-site departments to support the transfer of new products and processes from Research & Development or other Manufacturing Division sites to the Wilson site. Additionally, the role collaborates with site and global Packaging Technology as well as Global Engineering Services teams to specify, procure, install, and qualify new packaging and medical device assembly equipment.

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 assembly equipment and processes. Work requires a strong technical background and project management skills, as well as working knowledge of company methods, standards, procedures, and practices. Experience in complex equipment installation and qualification is desired for leading implementation of new technology or new applications of existing technology.

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. Strong communication skills are required to lead project sub-teams or be a key contributor on site and above-site sub-teams.

Responsibilities

• Provide technical assistance to packaging operations in the resolution of packaging and device assembly equipment problems for in-line products.
• Lead root cause analysis and author deviation investigations for process and equipment-related quality events.
• Provide technical support for the design, machinability evaluation, and qualification of new or modified packaging components and Medical Device and Combination Products.
• Provide technical support for the scale-up and technology transfer of pilot processes to production scale, including equipment design, qualification, process demonstration, process performance qualification, and process validation.
• Lead small-scale and support large-scale capital projects by partnering with Packaging Technology and Global Engineering Services on activities including equipment design, procurement, and qualification.
• Author process change controls and complete tasks to implement packaging and device assembly equipment or process changes.
• Build and enhance process robustness through designing and conducting line trials, analyzing equipment performance data, and implementing proactive process monitoring strategies.
• Contribute to the site’s permanent inspection readiness by authoring and reviewing technical documentation and providing support during regulatory audits.

Requirements

• BS in Engineering or equivalent and minimum of 1 year of experience with packaging or process equipment.
• Mechanical aptitude to troubleshoot and resolve equipment issues.
• Strong oral and written communication skills.
• Demonstrated teamwork skills.

Preferred Qualifications

• Experience in the 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.

Skills

• Required: Capital Projects, Global Engineering, Packaging Optimization, Packaging Processes, Procurement, Project Management, Teamwork, Technical Projects, Written Communication.
• Preferred: Lean Six Sigma (LSS), Six Sigma.

Pay

The salary range for this role is $87,300.00 - $137,400.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

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.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• Shift: 1st - Day
• Travel Requirements: 10%