Operator I

Job: Operator I
Duration: 6 Months
Location: Davie, FL

Job Description:

2nd Shift*

Shift Schedule: Monday – Friday 2:00PM to 10:30PM (Two 30-minute lunch breaks each)

Training Schedule: Start will be on a Monday. The first 2 to 3 days will be training from 8:00 a.m. – 4:30 p.m. EST then worker will begin their regular offered shift schedule by day 3 or 4 depending on how training goes. The client will notify worker when to begin the regular shift schedule.

Temp to perm: Yes depending on openings and performance

Core Essential Skills:

2) High school diploma or GED certificate
2) GMP experience .
3) Manufacturing experience in a regulated environment, with pharmaceutical experience being a plus.
4) Mechanical aptitude, including the ability to assemble, disassemble, clean, and operate manufacturing equipment.
5) Ability to follow Standard Operating Procedures (SOPs) and work safely within FDA, DEA, OSHA, and other regulated manufacturing guidelines.
6) Willingness to complete the required training and certification process before working independently.
7) Strong attention to detail and the ability to adapt to different production activities, including equipment operation, cleaning, changeovers, and solution preparation.
8) This role will require workers to climb ladders using a lift or a ladder up to 15 ft for cleaning and some setup procedures. This would occur 2-3 times per week.

Day-to-Day Responsibilities

• Operate pharmaceutical manufacturing equipment used in tablet production.
• Assemble and disassemble manufacturing equipment.
• Perform equipment cleaning and changeovers between product batches.
• Prepare solutions and support manufacturing processes.
• Follow Standard Operating Procedures (SOPs) and GMP requirements.
• Responsibilities vary depending on the production stage (operation, cleaning, setup, etc.).

Training

• Approximately 3 months of structured training/shadowing (up to 6 months depending on experience).
• Employees work alongside qualified operators until certified.
• Operators work independently only after completing required qualifications/certifications.

Essential Duties & Responsibilities:

This role will require workers to climb ladders using a lift or a ladder up to 15 ft for cleaning and some setup procedures. This would occur 2-3 times per week.

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
• Reports process or equipment problems to supervisor; performs minor or basic troubleshooting.
• Ensures batch records, equipment log books, and other relevant records are current; performs batch record reconciliation.
• Maintains records of manufacturing process by recording data on batch record.
• Sets-up and operates equipment for processing operations.
• Communicates effectively with previous and incoming shift operator and related personnel.
• Cleans and maintains processing rooms and equipment.
• Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
• Monitors product quality.
• Performs reconciliations.
• Conducts in-process testing.
• Checks and adjusts calculations.
• Checks/reviews labels and batch records for accuracy.
• Suggests improvements in methodology or process.
• Understands concept of delivery/on-time production.
• Follows established department SOP’s and batch record instructions.
• Complies with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.


Position Requirements:
Education Required/Preferred: High School Diploma or equivalent.
Experience Required: Prefer 0-1 year of work experience in a Manufacturing environment.
Physical Requirements: Incumbents in this class are subject to regular and/or routine periods of sitting, standing, walking, stooping, reaching, and climbing, visual acuity to monitor and/or read, communicating orally with Company management, peers and co-workers, and occasional periods of moving and lifting a minimum of 35 pounds. Work is performed in a manufacturing environment with noise levels varying from moderate to loud depending upon machinery usage. Work performed may require the use of a respirator and incumbents may be subject to a Pulmonary Function Test (PFT) to determine eligibility for fit-testing.
Specialized or Technical Knowledge Licenses, Certifications needed: N/A


Job-specific Competencies:

1. Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
Effective oral and written communication skills.
3. Basic math skills.
4. Complying with all Company safety rules and regulations.