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, performs quality inspections to identify and remove sub-standard quality softgels and foreign materials from product lots according to Standard Operating Procedures and applying current Good Manufacturing Practices (cGMP). Programs and operates machines that clean and count capsules in the final stage of the production cycle. Packages capsules in cartons and loads sealed cartons for shipment staging.

III.  Specific Activities, and Responsibilities:

Accurately completes documentation related to the Finishing process.Inspects softgels to either approve or reject for quality.  Performs re-inspection when necessary.Handles tray stacks and stages stacks for inspection or packaging.Inspects and cleans empty trays for use in the production cycle.Operates softgel washers and counting line machines, including scales.  May be required to operate softgel printing machines.Performs line clearances between product lots.Packages softgels in bulk and properly identifies cartons of softgels with product labels.Transfers sealed cartons of softgels in box room or warehouse, when necessary.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 regarding potential quality issues which may require QA notification.Cross - training to perform tasks, operate equipment and maintain the necessary documentation in other production departments will be required.Depending on shift staffing level and/or the workload, an operator could be assigned to perform tasks in an area 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.Previous manufacturing experience and work in a GMP regulated industry preferred

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 30 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 144 kg (approximately 460 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.In addition, will be required to operate industrial machinery. Must be able to access manufacturing floor

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. Job requires the ability to operate machines as well as monitoring additional machines during breaks, lunches or other periods when machines are not manned. Some exposure to industrial chemicals, detergents and flammable materials. 

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 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.

California Job Seekers can find our California Job Applicant Notice HERE.