Specialist, Operations (Night Shift)
Merck
Summary
The Operations Specialist will be an energetic individual with strong interpersonal, leadership, and collaboration skills responsible for supporting shop floor execution, batch closeout, and general troubleshooting. This role will contribute directly to the overall performance and results of the VMF 102 department. This position is on-site and is a rotating 12-hour shift on night shift following the 2-2-3 schedule.
Job description
Responsibilities
- Partnering with the Operations management team to create and execute strategies that support design, development, delivery and evaluation of projects related to steady-state production and/or continual process improvement
- Authoring and reviewing documents and SOPs
- Batch Record Review
- eLog Review
- Lead safety investigations
- Lead Problem Solving initiatives
- Equipment and process troubleshooting
- Supporting on-shift Operations Coaches (M1)
- Author deviations and works to coordinate, develop and implement Corrective Actions/Preventive Actions (CAPAs)
- Lead implementation of MPS principles on the shop floor
- Sample management
- Ability to effectively support, upskill and mentor new employees
- Analyzing and implementing initiatives that will help to increase overall success within the department
- Effectively using metrics and measurement to ensure that projects and initiatives result in desired outcomes
- Ability to prioritize workload under guidance from management
Education Minimum Requirement
- High School Diploma AND at least Five (5) years in a manufacturing, technical, support, or Military role
- OR Bachelor's degree in a technical field AND at least Three (3) years in a manufacturing, technical, support, or Military role
- Bachelor's degree and at least One (1) year of experience in a direct GMP, biotechnology, manufacturing setting
Required Experience and Skills
- Experience working in a GMP environment
- Demonstrated written and verbal communications skills
- Ability to foster a collaborative work environment
- Demonstrated interpersonal, technical aptitude, and problem-solving skills
- Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
- Must be flexible and able to manage multiple priorities
Preferred Experience and Skills
- Understanding of MPS methodologies
- Experience with shop-floor cGMP manufacturing and related systems (i.e. SAP)
- Familiarity with pharmaceutical regulatory requirements
- Project management and data analysis skill
- Technical writing experience
- Experience with facility, equipment and/or process start up activities in a cGMP environment
- Demonstrated ability to work independently
- Production planning / scheduling experience
Requirements
- High School Diploma AND at least 5 years in a manufacturing, technical, support, or Military role OR Bachelor's degree in a technical field AND at least 3 years in a manufacturing, technical, support, or Military role
- Bachelor's degree and at least 1 year of experience in a direct GMP, biotechnology, manufacturing setting
- Experience working in a GMP environment
- Demonstrated written and verbal communications skills
- Ability to foster a collaborative work environment
- Demonstrated interpersonal, technical aptitude, and problem-solving skills
- Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict
- Must be flexible and able to manage multiple priorities
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.