Specialist, Operations (Night Shift)

Merck • Durham, NC

1d • $79,200 - $124,700 • Onsite

About The Position

The Operations Specialist supports shop floor execution, batch closeout, and general troubleshooting, contributing directly to the performance and results of the VMF 102 department. The role partners with Operations management to plan and execute strategies for steady-state production and continual process improvement, and supports Operations Coaches on shift. This is an on-site role on a rotating 12-hour night shift following a 2-2-3 schedule.

Requirements

• High school diploma and at least five years of experience in a manufacturing, technical, support, or military role; or a bachelor's degree in a technical field and at least three years of such experience; or a bachelor's degree and at least one year of experience in a direct GMP, biotechnology, or manufacturing setting.
• Experience working in a GMP environment.
• Demonstrated written and verbal communication skills.
• Ability to foster a collaborative work environment.
• Demonstrated interpersonal, technical aptitude, and problem-solving skills.
• Strong teamwork skills, including coaching and developing work teams, providing training, motivating and empowering others, and resolving conflict.
• Flexibility and ability to manage multiple priorities.

Nice To Haves

• Understanding of MPS methodologies.
• Experience with shop-floor cGMP manufacturing and related systems such as SAP.
• Familiarity with pharmaceutical regulatory requirements.
• Project management and data analysis skills.
• Technical writing experience.
• Experience with facility, equipment, or process startup activities in a cGMP environment.
• Demonstrated ability to work independently.
• Production planning or scheduling experience.

Responsibilities

• Partner with the Operations management team to create and execute strategies for projects related to steady-state production and continual process improvement.
• Author and review documents and standard operating procedures.
• Review batch records and eLogs.
• Lead safety investigations and problem-solving initiatives.
• Troubleshoot equipment and processes.
• Support on-shift Operations Coaches (M1).
• Author deviations and coordinate, develop, and implement Corrective Actions/Preventive Actions (CAPAs).
• Lead implementation of MPS principles on the shop floor.
• Manage samples.
• Support, upskill, and mentor new employees.
• Analyze and implement initiatives to increase departmental success.
• Use metrics and measurement to ensure projects and initiatives achieve desired outcomes.
• Prioritize workload under management guidance.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

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