The Lead Operator is responsible for leading daily operations in a process area and ensures compliance with all site operating, Quality, cGMP, and safety procedures associated with manufacturing of bulk medicated feed additives (MFA).
- Serves as a leader by communicating, maintaining schedule awareness, being decisive, continuously learning, and leading others.
- Exercises sound judgement to make shift decisions independently, ensuring follow up with management.
- Drives the Lean Standard Work Culture:
- Update the metric board at the end of each shift.
- Lead shift hand off meeting
- Oversee/participate in maintenance activities when facility has downtime
- Ensure Batch Record review with having 100% right the first time.
- Ensures housekeeping is being completed.
- Evaluates process and production situations effectively and makes sound decisions.
- Understands and facilitates environmental compliance.
- Retains knowledge and is able to take readings, startup and shutdown equipment, recognize problems, follow cGMP, perform equipment cleanings, as needed.
- Performs minor disassembly and reassembly of equipment, as needed.
- Ensures GMP requirements are followed and communicate any GMP issues quickly and accurately. Performs advanced troubleshooting and problem resolution and provides direction to operators when production lines are down.
- Facilitates process improvement ideas.
- Leads in the training new operators and pairing of trainee and trainer. Ensures operators are trained on appropriate task / equipment.
- Delivers training on SOPs and Standard work.
- Maintains strong engagement in the production area(s).
- Follows and enforces all safety rules. Coaches others to do the same through normal operations and unusual situations.
- Plans and coordinates activities with maintenance, other shifts and other departments within the facility.
EDUCATION AND EXPERIENCE:
Applicants are required to have a high school diploma or equivalent (GED). 5+ years directly related experience and/or training or equivalent combination of education and experience is required.
TECHNICAL SKILLS REQUIREMENTS:
Applicants must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Demonstrated knowledge in relevant technical areas. Solid understanding of manufacturing processes, equipment and facilities.
- Demonstrated understanding of manufacturing operations in the pharmaceutical/bio-technology industry.
- Strong verbal and written communication skills. Can articulate issues and solutions to the team.
- Ability to clearly convey ideas, instructions, or directions.
- Can effectively interact and collaborate with team members. Demonstrates respect for others and encourages team participation.
- Ability to maintain a positive attitude, high level of enthusiasm, and a solid commitment to both personal and company objectives.
- Ability to effectively lead others.
- Can analyze problems and provide support in determining appropriate corrective and preventative actions, with minimal assistance.
- Capable of simultaneously managing multiple assignments.
- Prioritizes own work. Flexible and responsive to changes.
- Demonstrated history of regular and predictable attendance.
- Computer proficiency with email; internet/online training; and working knowledge of Microsoft Office.
PHYSICAL POSITION REQUIREMENTS: The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to accomplish moderate lifting, repeatedly move up to 55 lbs.
- Regularly required to sit, stand, bend, reach and move about the facility.
- Ability to operate a fork truck safely and efficiently.
- Bending, stooping, squatting, pushing and pulling can also be expected.
- Specific vision abilities required include close vision, distance vision, peripheral vision and depth perception.
- Use of required personal protective equipment is required.