Specialist, Operations 2nd Shift Weekend

Merck & Co. - West Point, PA

Full-time - Entry Level

Onsite - West Point, PA

Chemical Manufacturing

About the position

The Specialist, Operations plays a crucial role in supporting manufacturing operations within the Vaccines HPV Bulk IPT organization. This high-impact position ensures that all products manufactured adhere to current Good Manufacturing Practices (cGMPs), operating procedures, and other applicable regulations. The focus of this role is on continuous improvement, compliance on the shop floor, and the implementation of lean manufacturing initiatives that align with departmental goals. The position operates on a 2nd shift schedule from Tuesday to Saturday, from 4 PM to 12 AM. In this role, the Specialist assists managers in the direct processing of materials to achieve business results. They are expected to develop a comprehensive understanding of the equipment and processes involved in manufacturing. Building knowledge of the company, processes, clients, and customers is essential. The Specialist applies team effectiveness skills, actively listens, and integrates diverse perspectives from across the workgroup. Managing conflict and resolving technical and personal challenges using standard procedures is key, as is the openness to change and the ability to effect positive change. The Specialist contributes to the achievement of team goals and is involved in tool development for shop floor execution and operability of manufacturing processes. Under the guidance of an Associate Director, the Specialist is responsible for ensuring compliance with safety and environmental practices, cGMPs, and Standard Operating Procedures (SOPs) in their work area. They must demonstrate integrity, credibility, and flexibility in their daily performance to motivate others. The Specialist performs thorough reviews of batch records and related GMP documentation, identifying and resolving discrepancies promptly while implementing corrective actions to enhance the batch record execution and review process. They work closely with Subject Matter Experts (SMEs) to provide and track necessary training for operator qualification as assigned, and participate in designing and implementing training and development programs and materials. Establishing and implementing effective corrective and/or preventative actions (CAPAs) to prevent the recurrence of deviations is also a critical responsibility, ensuring improvements in the Right First Time metrics.

Responsibilities

• Ensure compliance with safety and environmental practices, cGMPs, and Standard Operating Procedures (SOPs) in the work area.
• Perform thorough reviews of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner.
• Work with Subject Matter Experts (SMEs) to provide and track necessary training for operator qualification as assigned.
• Participate in the design and implementation of training and development programs and training materials.
• Foster a mutually beneficial relationship with manufacturing floor personnel focused on high-quality investigations and meaningful corrective actions.
• Establish and implement appropriate and effective corrective and/or preventative actions (CAPAs) to prevent reoccurrence of deviations.
• Identify and solve a range of problems in straightforward situations; analyze possible solutions and assess each using standard procedures.
• Make decisions guided by site policies and procedures, consulting with managers on complex decisions that impact other departments.
• Contribute to project teams or sub-teams, managing or leading small project teams as necessary.
• Partner with team members in identifying and implementing continuous improvement initiatives and action plans.

Requirements

• Bachelor's degree or higher in Science, Engineering, Business Administration, or another technical field, or a High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service.
• Demonstrates strong leadership capability and problem-solving skills with a hands-on approach.
• Ability to work independently and willingness to work off-shift and weekends as needed.

Nice-to-haves

• People management background.
• One to two years of cGMP experience in a sterile, bulk, or finished pharmaceutical environment.
• Manufacturing plant experience in an operational capacity.
• Experience in a union environment.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Paid holidays
• Paid time off (PTO)
• Flexible scheduling options
• Professional development opportunities