Catalent
pharmaceutical
OperationsTechnicianI
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“Operations Technician I at Catalent. Skills: Manufacturing, Documentation, cGMPs. Follow manufacturing Master Batch Records (MBRs) and Standard Operating Procedures (SOPs). Prepare production batch requirements”
What You'll Achieve.
Focus on “right first time” execution; Ensure data integrity
Industry & Context.
Visual troubleshooting of equipment
Ability to lift to 50 pounds, Must be able to wear a respirator, 20/20 vision (with eye correction)
What They're Looking For.
Must Have
High School Diploma or GED, at least 6 months of pharmaceutical experience or completion of Grads2Work Program, BioWorks certificate program or equivalent Manufacturing experience, ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or talk and hear, smell and lift to 50 pounds, Steel toe/ composite shoes are required to be worn on manufacturing floor, able to wear a respirator, 20/20 vision (with eye correction); Specific vision requirements include inspecting product for defects, reading of written documents, visual troubleshooting of equipment and use of computer monitor screen frequently
What You'll Do.
Follow manufacturing Master Batch Records (MBRs) and Standard Operating Procedures (SOPs)
Prepare production batch requirements
Review product paperwork
Document in real-time during manufacturing processes
Clean rooms or equipment as required
Perform commercial manufacturing of clinical supplies
Assist in scale up of pilot development trials
Manufacture of Pulmonary & Nasal Products
Comply with divisional and site Environmental Health and Safety requirements
How You'll Work.
Team & Collaboration
Working closely with customers and R&D scientists
Full Job Description
**Operations Technician I** **Position Summary:** * **Work Schedule:** Monday - Friday, 6:00am to 2:30pm * 100% on-site The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. The Operations Technician I, performs commercial manufacturing of clinical supplies working closely with customers and R&D scientists in the development and scale up of new products and processes. Assists in the scale up of pilot development trials to production processes and is primarily responsible for the manufacture of Pulmonary & Nasal Products, as well will comply with divisional and site Environmental Health and Safety requirements. **The Role:** * Accurately follows manufacturing Master Batch Records (MBRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on “right first time” execution * Prepare and assist in the preparation of all production batch requirements * Review product paperwork to ensure use of proper materials and equipment * Accurately document in real-time as required during all manufacturing processes paying strict attention to detail to ensure data integrity * Following specific cleaning procedures or department cleaning SOP's, clean rooms or equipment as required * Other duties as assigned **The Candidate:** * Must have High School Diploma or GED * Must have at least 6 months of pharmaceutical experience or completion of Grads
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