Gel Prep 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: Under supervision, prepare, blends and mixes batches of material by operating blending equipment 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 Gelatin process. Measures and weighs, by manual and computerized scales, gelatin and dyes used in gelatin batches. Processes gelatin master batches and color conversion per applicable SOP and batch record instructions. Operates production equipment as required per applicable SOP. Washes, inspects and sanitizes gelatin receivers and equipment. Performs work according to safety policies and practices related to the position. Handles non-hazardous, hazardous and DEA waste. Maintains a clean work area. Notifies Supervision immediately in the event that 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 areas, different than her/his primary position/business unit. Update SOPs for assigned department as needed IV. Knowledge Requirements: Education or Equivalent: High School diploma or equivalent required. Knowledge/Skills Requirements: Previous manufacturing experience and work in a GMP regulated industry preferred. 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 English instructions furnished in written, oral, diagram, or schedule form. Ability to multi-task and meet deadlines under pressure Physical/Mental Requirements: Individual required to sit rarely, 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). Successful completion of Lung Capacity test and ability to wear respirator 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. Must be able to operate industrial machinery. Must be able to access manufacturing floor. Previous manufacturing experience and work in a GMP regulated industry preferred. 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. To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy. 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. 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 [email protected] . 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 [email protected] for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .

Requirements

High School diploma or equivalent required.
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 English instructions furnished in written, oral, diagram, or schedule form.
Ability to multi-task and meet deadlines under pressure
Individual required to sit rarely, 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).
Successful completion of Lung Capacity test and ability to wear respirator
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.
Must be able to operate industrial machinery.
Must be able to access manufacturing floor.

Nice To Haves

Previous manufacturing experience and work in a GMP regulated industry preferred.
Basic computer skills including Windows navigation and data entry.
Previous manufacturing experience and work in a GMP regulated industry preferred.

Responsibilities

Accurately Completes documentation related to the Gelatin process.
Measures and weighs, by manual and computerized scales, gelatin and dyes used in gelatin batches.
Processes gelatin master batches and color conversion per applicable SOP and batch record instructions.
Operates production equipment as required per applicable SOP.
Washes, inspects and sanitizes gelatin receivers and equipment.
Performs work according to safety policies and practices related to the position.
Handles non-hazardous, hazardous and DEA waste.
Maintains a clean work area.
Notifies Supervision immediately in the event that 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 areas, different than her/his primary position/business unit.
Update SOPs for assigned department as needed