EW Encapsulation Operator (Nights) D shift

Company: Catalent Pharma Solutions, Inc.
Location: Saint Petersburg
Posted on: June 18, 2022

Job Description:

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

IV. Knowledge Requirements:

Education or Equivalent:

* 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.
* Previous manufacturing experience and work in a GMP regulated industry preferred.
* Successful completion of Lung Capacity test and ability to wear respirator

Knowledge/Skills Requirements:

* 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

Physical/Mental Requirements:

* 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

Business Environment:

Individual's primary workstation is in the manufacturing area, where the noise level is high. Work schedule may include 12-hours shift, days, nights and/or weekends including overtime as required. Some exposure to industrial chemicals and detergents. Some handling of flammable materials and potent drug compounds.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

Keywords: Catalent Pharma Solutions, Inc., St. Petersburg , EW Encapsulation Operator (Nights) D shift, Other , Saint Petersburg, Florida