ESSENTIAL DUTIES AND RESPONSIBILITIES:- Production Oversight: Manage daily manufacturing and packaging activities to meet customer specifications and production schedules.
- Regulatory Compliance: Ensure adherence to Good Manufacturing Practices (GMP) and all federal, state, and local safety and environmental regulations (OSHA, EPA).
- Quality & Integrity: Oversee the implementation of Standard Operating Procedures (SOPs) and drive root cause analysis and Corrective and Preventive Actions (CAPA) for any deviations.
- Financial Management: Develop and manage annual operating plans (AOP) and capital budgets; track profit and loss (P&L) performance while identifying cost-saving initiatives.
- Client & Stakeholder Relations: Act as a key point of contact for external clients, ensuring their product requirements are met and fostering trust through transparent performance reporting.
- Strategic Planning: Lead facility expansions, technology upgrades (such as AI and IoT integration), and the onboarding of new product lines.
- Team Leadership: Recruit, train, and mentor a high-performing workforce, fostering an environment of accountability, collaboration, and safety.
- Oversee all day-to-day facilities management including all non-GMP maintenance activities.
- Provide leadership for employees through effective communication, coaching, training, and development.
- Manage efficient utilization of personnel, material usage and waste, control of variable manufacturing costs and overhead.
- Establish a manufacturing plan to include specific departmental goals and objectives and effectively communicate those to all levels.
- Together with Engineering and Quality, evaluate, manage and implement process and procedural changes designed to improve productivity, capacity and overall efficiency while maintaining a culture that emphasizes safety and regulatory compliance.
- Drive Sales and Operations Planning (S&OP) activities to forecast and manage anticipated changes in staffing requirements and equipment capacities.
- Support company growth initiatives, by working with other departments to ensure new products, processes, and plans are delivered within established time frames, budgets and guidelines.
- Regular attendance.
- Adhere to company safety requirements.
MINIMUM REQUIREMENTS:- Bachelor's degree in Engineering or a related technical field or an equivalent combination of education and experience.
- Seven years' related management experience in a manufacturing environment.
- Experience in a FDA regulated manufacturing facility, with a demonstrated ability to implement systems that promote GMP compliance preferred.
- Familiarity with ISO 9001 and ISO 13485 preferred.
- Knowledge of Lean Manufacturing techniques.
- Experience with materials and inventory management, production scheduling, and preventive maintenance.
- Excellent communication and interpersonal skills.
- Ability to manage multiple projects and prioritize meeting established timelines and organizational commitments.
- Proficient with Microsoft Office (Word, Excel, Project).
PHYSICAL REQUIREMENTS:- Frequently required to sit, talk, and hear.
- Frequently required to stand and walk.
- Occasionally required to lift and/or move up to 50 pounds (23kg).
- Occasionally required to climb.
- Occasionally required to work with cleaners, solvents, and chemicals. MSDS sheets are provided.
- Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
Starting Wage $160,000.00 DOE
LIMITATIONS AND DISCLAIMERThe above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.
Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Continued employment remains on an "at-will" basis.
