Business Title: Manufacturing Team Lead
contractor to hire
Shift 1 (7:00 am-3:30 pm); approximately 4-8 hours of overtime will be required each week
Shift 2 (3:00 pm-11:30 pm); approximately 4-8 hours of overtime will be required each week
Candidates should not have allergies to either Penicillin or Cephalosporin and must certify they do not have the allergy
The Manufacturing Technician 4 is responsible for executing all processes in production. Under the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area while strictly adhering to current Good Manufacturing Practices, Specifications, Standard Operating Procedures, Job-Specific Training Materials, environmental health and safety guidelines and any other related regulations which could apply. He/She fully understands the regulations and may make recommendations according to their interpretations. The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. He/She is responsible for the successful transfer of new processes/methodologies into the manufacturing area. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable.
1. Assist supervisor in organizing, scheduling and directing other team members.
2. Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, validation.
3. Involved in hands-on execution of manufacturing operations.
4. Ensure timely and accurate generation of process documentation. Review documentation.
5. Resolve issues related to equipment, process and compliance. Main troubleshooting/response person.
6. Investigate any process problems timely and provide documentation.
7. Participate on Continuous Improvement Teams and may serve in a leadership role.
8. Responsible for training execution, which includes planning and presentation.
9. Mentor other team members and monitor training for newer team members.
10. Assist with process/equipment validation and data analysis.
11. Assign other project work and/or involvement in teams to team members.
12. Represent the dept. in cross functional teams as necessary.
13. Perform other duties as assigned.
In-depth process knowledge of related manufacturing techniques and specialties.
* Must have good written and verbal communication skills and understanding of cGMP regulations. Good procedural writing skills.
* Familiarity with pharmaceutical production equipment including but not limited to: Mixing, Filling, Finishing, and Clean-In-Place / Steam-In-Place.
* Must be able to read and follow detailed written instructions.
* Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
* Must be able to apply quantitative analysis to analyze process performance.
* Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.
* This position requires shift, weekend and holiday work. Overtime may be required at times.
* The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
* Knowledge of basic chemical and biological safety procedures.
* Good computer skills
Education / Experience
Requires Bachelors with a minimum or 2-3+ years of experience or AA degree with 4-6 years of experience or completed high school diploma with ?6 years related manufacturing experience.
Software: Microsoft Office Suite; SAP or JDE experience, nice to have
Leadership experience, organization, team players, strong communications skill
Exposure / experience with inventory management, build sheets, etc.
• Requires continuous grasping, pushing/pulling up to 15 pounds and reaching with hands and arms.
• Lifting and carrying on average up to 15 pounds frequently throughout the shift.
• Normal visual acuity and the ability to distinguish color are necessary.
• Have the ability to complete quick and precise repetitive processes using both arms and both hands
• Must be able to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance
Repairing (Computer Systems)
Troubleshooting (Problem Solving)