Specialist, Operations (Night Shift)
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 position partners with the Operations management team on strategies and projects for steady-state production and continual process improvement. It is onsite in Durham, North Carolina, and follows a rotating 12-hour night-shift schedule using a 2-2-3 pattern. The role involves production documentation and record review, safety and problem-solving leadership, equipment and process troubleshooting, support for on-shift Operations Coaches, deviation and CAPA coordination, implementation of MPS principles, sample management, and helping train and mentor employees. The Specialist also analyzes and implements initiatives, uses metrics to evaluate outcomes, and prioritizes work under management guidance. Candidates must meet one of the stated education and experience pathways: a high school diploma and at least five years in a manufacturing, technical, support, or military role; a technical bachelor’s degree and at least three years in such a role; or a bachelor’s degree and at least one year of direct GMP, biotechnology, or manufacturing experience. GMP experience and strong communication, collaboration, problem-solving, coaching, and prioritization skills are required.
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 in such a role; OR a bachelor’s degree and at least one year of direct GMP, biotechnology, or manufacturing experience.
- 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 team 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, and/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 involving steady-state production and continual process improvement.
- Author and review documents and SOPs.
- 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 overall departmental success.
- Use metrics and measurement to evaluate whether projects and initiatives achieve desired outcomes.
- Prioritize workload under management guidance.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Other insurance benefits for employees and families
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
