|| Director of Operations
||Consumer Packaged Goods, Engineering, Operations and Supply Chain
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Plans, directs and participates in the hands-on activities of maintenance function, equipment sourcing/installation, building projects to ensure that goals and objectives within prescribed time and funding parameters, and the facilities function.
- Directs planning and execution of facility design changes to compliment operational needs while staying in compliance with procedural, GMP and customer requirements.
- Directs the planning and execution of all HVAC projects and trains facility staff on appropriate HVAC processes.
- Investigates new equipment, technologies and facility structure in the pre-planning stages of a project and determines the appropriate equipment and facility design for the application.
- Directs and participates in activities supporting equipment receipt, installation, testing and verification and/or validation to conform to GMP and customer requirements. In particular, developing and executing FAT, IQ, OQ and PM protocols.
- Actively participates as a leader on the tech. transfer team.
- Provides technical support and solutions to MFG groups regarding the best utilization of equipment and MFG/packaging processes.
- Reviews and/or authors technical reports and documents for accuracy content and approve final documents.
- Manages project capital spending within established guidelines.
- Manages documentation program for maintenance and facilities documents.
- Reviews and implements necessary changes to support preventative maintenance program to include management of spare parts inventory.
- Ensures safety regulations are followed and properly documented to provide a safe work environment for employees.
- Manage, review and write appropriate Standard Operating Procedures (SOP) to support GMP operations in supervised departments.
- Coaches and mentors department managers and supervisors, increasing the performance of the entire team.
- Prepares and executes within department budgets.
- Supports all departments with other projects as necessary
|Desired Skills and Experience:
EDUCATION AND EXPERIENCE:
- Bachelor’s degree in Engineering or related manufacturing field.
- 10 years’ experience working in a regulated environment at a Good Manufacturing Practices (GMP) facility.
- 5-10 years’ experience with various dosage forms including tablets, powders and liquids or gels. Including, packaging formats of bottles, tubes, sachets and sticks.
- 5-10 years management experience directing maintenance and facilities operations and supporting research and development activities at a dietary supplement (or related) manufacturing company.
- Demonstrated experience in writing and executing FAT, IQ, OQ and new equipment related PM protocols.
- Experience interacting with the FDA, 3rd party firms (NSF) and customers during audits.
- Experience participating in resource planning and other planning initiatives.
KNOWLEDGE, SKILLS AND ABILITIES:
- Demonstrated knowledge of 21 CFR parts 111 and/or 211.
- Proven ability to work independently and make solid decisions with little supervision and direction.
- Ability to make decisions based on the appropriate scientific (fact based) approach and risk assessment.
- Ability to clearly articulate directions, maintenance and facilities processes, formulations (to support R&D as needed) etc. to staff and customers verbally and in writing.
- Ability to develop and execute career development plans for individual employees while coaching, mentoring and training on a regular basis.
- Ability to be innovative and think creatively while maintaining budgets.
- Ability to plan large scale and small scale projects and to change project plans to meet immediate needs with little notice.
- Excellent knowledge of current engineering, manufacturing and research and development practices.
- Working knowledge of cGMP, SOPs, protocols and validation.
- Working knowledge of the Microsoft Office Suite.
- Perform other duties and responsibilities as assigned.
|About Skywater Search Partners
Start with your short list.™
Led by a group of seasoned search industry professionals, SkyWater Search Partners brings new focus to a novel concept, “short list search”. Our purpose is to leave a lasting impression on the clients we serve by providing individuals who will make a measurable difference in their business. We strive to consistently deliver great results to our clients in a very timely manner.
Our practice areas are led by highly experienced executive recruiters who take great care in fully understanding client requirements and candidate qualifications.
– Accounting and Finance
– Consumer Package Goods (CPG)
– Human Resources (HR)
– Information Technology
– Sales and Marketing
– Supply Chain
Founded on long-standing relationships and hundreds of successful placements throughout the Twin Cities business community, SkyWater Search Partners is a proven resource for clients and candidates looking to quickly and confidently explore their “short list” of best choices. Count on us to find the best people – and the best fit.