Encapsulation Operator

Catalent•Petersburg, FL

3d•Onsite

About The Position

I. Department Overview: To provide a cGMP compliant manufacturing process and continuously improve the pharmaceutical manufacturing environment at Catalent. St. Petersburg. Create a workplace that is safe, clean, environmentally friendly, employee friendly, highly productive, efficient and of sufficient capacity to support the forecasted demand as predicted by Catalent Pharma Solutions. II. Basic Function: Manufactures softgels by operating an Encapsulation Machine and completing batch paperwork according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP). III. Specific Activities, and Responsibilities: Accurately completes documentation related to the Encapsulation process. Operates and maintains up to two Encapsulation Machines (and covers up to as many as four during breaks). Maintains a clean work area. Performs in-process checks and evaluates, in detail, product quality. Monitors material and gel usage at the machine and changes receivers as needed ensuring that components are not used past expiration date and time. Ensures empty receivers are transported back to respective departments as soon as possible. Monitors encapsulation process to minimize rejected product at the machine. Coordinates with crib mechanic in advance of and during changeover. Tears down machine at changeover if required (if utility unavailable) Sets-up/assembles Encapsulation Machine for operation per batch record instructions (if utility unavailable) within allotted time per department standards. Troubleshooting Equipment to maintain a quality product. Monitors and replenishes solvents and lubricants as required. Assembles, handles, and stages tray stacks with manufactured softgels. Ensures that needed supplies (tray paper, gloves etc.) for the department are maintained at sufficient levels. Handles non-hazardous, hazardous and DEA materials and waste. Performs work according to safety policies and practices related to the position. Notifies Supervision immediately if there is any deviation from the batch record, SOP or potential production event. Cross-training to perform tasks, operate equipment and maintain the necessary documentation in other production departments may be required. Depending on shift staffing level and/or the workload, an operator could be assigned to perform tasks in area, different than her/his primary position/business unit. Update SOPs for assigned department as needed. Utility Supports Encapsulation Operators during the manufacturing process by: Troubleshooting Equipment to maintain a quality product. Monitors and replenishes solvents and lubricants as required. Completes documentation related to the Encapsulation process during a changeover. Coordinates with crib mechanic in advance of and during changeover Tears down machine at changeover. Sets-up/assembles Encapsulation Machine for operation per batch record instructions. Monitors encapsulation process to minimize rejected product at the machine. Operates Encapsulation Machine, if required. Helps to maintain a clean work area on the encapsulation floor. Performs in-process checks and evaluates product quality. Assists operators with material and gel receiver changes as necessary - Ensures empty receivers are transported back to respective departments. Assembles, handles, and stages tray stacks with manufactured softgels. May be required to assume back-up roll to Shift Assistant. Ensures that needed supplies (tray paper, gloves etc.) for the department are maintained at sufficient levels

Requirements

High School diploma or GED required.
Visual acuity to inspect capsules for quality as they are being produced and for making detailed adjustments to the equipment.
Successful completion of Lung Capacity test and ability to wear respirator
Basic computer skills including Windows navigation and data entry.
Must be able to read, write and communicate in English.
Ability to read, interpret and execute written instructions.
Ability to add, subtract, multiply, divide and combine units of measure.
Ability to calculate fractions and decimals.
Ability to solve practical problems.
Ability to interpret and perform work against a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to multi-task and meet deadlines under pressure
Individual may be required to sit intermittently, stand regularly, walk regularly and consistently lift to 50 pounds; no lifting greater than 44.09 pounds without assistance, for a work period of up to 12-hours.
Ability to push and/or pull on average 500 kg (approximately 1,100 pounds).
Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses.
For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
Read written documents and frequent use of a computer monitor.
Required to operate industrial machinery.
Must be able to access manufacturing floor.
Must be able to withstand heights, climb ladder, walk, stand, sit, kneel, lay to perform repairs

Nice To Haves

Previous manufacturing experience and work in a GMP regulated industry preferred.

Responsibilities

Accurately completes documentation related to the Encapsulation process.
Operates and maintains up to two Encapsulation Machines (and covers up to as many as four during breaks).
Maintains a clean work area.
Performs in-process checks and evaluates, in detail, product quality.
Monitors material and gel usage at the machine and changes receivers as needed ensuring that components are not used past expiration date and time.
Ensures empty receivers are transported back to respective departments as soon as possible.
Monitors encapsulation process to minimize rejected product at the machine.
Coordinates with crib mechanic in advance of and during changeover.
Tears down machine at changeover if required (if utility unavailable)
Sets-up/assembles Encapsulation Machine for operation per batch record instructions (if utility unavailable) within allotted time per department standards.
Troubleshooting Equipment to maintain a quality product.
Monitors and replenishes solvents and lubricants as required.
Assembles, handles, and stages tray stacks with manufactured softgels.
Ensures that needed supplies (tray paper, gloves etc.) for the department are maintained at sufficient levels.
Handles non-hazardous, hazardous and DEA materials and waste.
Performs work according to safety policies and practices related to the position.
Notifies Supervision immediately if there is any deviation from the batch record, SOP or potential production event.
Cross-training to perform tasks, operate equipment and maintain the necessary documentation in other production departments may be required.
Depending on shift staffing level and/or the workload, an operator could be assigned to perform tasks in area, different than her/his primary position/business unit.
Update SOPs for assigned department as needed.
Troubleshooting Equipment to maintain a quality product.
Monitors and replenishes solvents and lubricants as required.
Completes documentation related to the Encapsulation process during a changeover.
Coordinates with crib mechanic in advance of and during changeover
Tears down machine at changeover.
Sets-up/assembles Encapsulation Machine for operation per batch record instructions.
Monitors encapsulation process to minimize rejected product at the machine.
Operates Encapsulation Machine, if required.
Helps to maintain a clean work area on the encapsulation floor.
Performs in-process checks and evaluates product quality.
Assists operators with material and gel receiver changes as necessary - Ensures empty receivers are transported back to respective departments.
Assembles, handles, and stages tray stacks with manufactured softgels.
May be required to assume back-up roll to Shift Assistant.
Ensures that needed supplies (tray paper, gloves etc.) for the department are maintained at sufficient levels