EW Encapsulation Operator (Nights) D shift
Company: Catalent Pharma Solutions, Inc.
Location: Saint Petersburg
Posted on: June 18, 2022
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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
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