Catalent Pharma Solutions ADT Operations Technician (1st Shift) in Somerset, New Jersey
Specific Tasks, Duties and Responsibilities:
Level I * Understand and follow all CGMP and SOP regulations * Ability to show proficiency in gowning and use of PPE as required * Weigh and transfer materials using calibrated scales and balances * Perform detailed cleaning of manufacturing suites and equipment using various cleaning solutions * Use various types of equipment to mix/combine materials for use in production * Accurately complete all applicable documentation pertaining to daily tasks (Batch Records, Logbooks, Protocols, etc.) * Interact with customers and visitors * Perform basic calculations with aid of a calculator * Understand and accurately follow written instructions/batch records * Cooperate seamlessly with Team Leader and Supervisor * Maintain a clean and safe work environment * Follows all safety guidelines as directed in batch documentation * Perform tasks within a team
* Must be Grade I for no less than (1) year * Must successfully complete Grade II exam * Grade II should be comfortable with all documentation including the verification of work performed by others * Show significant technical skills related to job, e.g., machine set-up and operation, understanding of all machine controls/functions, ability to troubleshoot, etc. * Must demonstrate technical understanding within the facility, with ability to work between areas as needed and expertise in at least one technology. * Possess problem solving and decision-making skills as related to job * May be asked to aid in training of new employees
Level III * Must be Grade II for a minimum of (2) years * Must successfully complete Grade III assessment * Must demonstrate a more advanced technical understanding across the entire facility, with ability to work between areas and expertise (SME) in at least three separate technologies * Should be comfortable with all aspects, responsibilities and procedures required to complete all tasks * At least two years of Strong/Leading performance management ratings * Demonstrate strong leadership skills, e.g., takes ownership of the process, always works safely donning the proper PPE, mentors/trains new operators, etc * Demonstrate strong technical skills at and above those expected of Levels I-II, consistently troubleshooting and displaying exceptional problem solving skills * Actively participate in the training of new employees * Ensure accurate and adequate documentation through label verifications, batch record reviews, etc. with limited PR’s and batch record corrections
Level IV * Must be Grade III for a minimum of (2) years * Must demonstrate broad technical understanding across the entire facility, with ability to work between areas and expertise (SME) in at least four separate technologies * Must have demonstrated outstanding troubleshooting skills and ability to anticipate critical customer issues * Must be self-directed, requiring minimal supervision * Safety role model, consistently demonstrating safe work habits and identifying unsafe conditions * At least two years of Strong/Leading performance management ratings * Demonstrate outstanding initiative, i.e., develops and implements process improvements and safety measures, anticipates issues and takes preventative measures as necessary, has no attendance issues and routinely volunteers for overtime, actively participates in various process improvement committees, and constantly demonstrates exceptional customer service * Technical expert in a variety of different areas with the ability to operate multiple pieces of equipment * Ability to lead new product campaigns with successful completion * Stand in for Team Leader in their absence * Possess outstanding communication skills: * Written – Exemplary documentation with limited PR’s and batch record corrections * Verbal – Actively participates in customer visits and audits
- Minimum of a High School Degree with a two year technical or Associate’s degree preferred.
- Prior experience working in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements) is preferred; with specific experience in oral solid dosage manufacturing (blending, compression, pan coating, fluid bed, Softgel, Zydis or encapsulation manufacturing processes).
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
Level I & Level II * Perform basic math calculations * Ability to utilize hand tools to assemble and disassemble various types of machinery * Ability to follow instructions and procedures (SOPs, cGMPs) * Work in a safe manner * Legible hand writing skills * Proficient reading and comprehension skills * Some decision-making, technical and problem solving skills
Level III * All requirements listed above for both Levels I & II * Strong leadership skills * Strong decision making skills * Technical skills/trouble shooting skills
Level IV * All requirements listed above for Levels I-III * Demonstrate a high level of Technical expertise and problem solving skills. * Exemplary leadership skills, demonstrate the ability to lead project team (coach, mentor team members)
- Shifts of 8 or 12 hours in duration
- Encapsulation Only - Individual must also be able to pass standardized color plate performance (HRR: PSEUDOISOCHROMATIC PLATES) and have corrected or uncorrected visual acuity of 20/30 near vision.
- Handling of raw materials for product assembly
- Manipulation of drums to and from 6-inch pallets
- Drum weight <10kg. (Empty) to 150kg (max. full weight) up to 30 times per shift
- Maneuvering of drums in lab consisting of rolling, scooting, pushing and pulling (up to 80 lbs. of force)
- Utilization of scoops and other hand held implements
- Lifting boxes and/or containers up to 40 lbs. (18.2 kg) from waist to chest height
- Loading product of various amounts of completion to counters and quality control devices
- Overhead lift and reach (≤15 lbs.)
- Handling of finished product
- Manipulation of drums to and from 6-inch pallets (up to 80 lbs. of force)
- Push and pull ingredient canisters
- Cleaning of Lab and equipment
- Utilizing hand held brushes, wands, hoses, and other cleaning utensils
- Operating in various postures
- Overhead reach, squatting, kneeling, and forward bending
- Transport of materials to and from designated lab space
- Use of various job task dependent tools and work saver equipment including pallet jacks
- Coordination in a laboratory setting, e.g., climbing up/down ladders or maneuvering around drums or between equipment
- Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Organization: Advanced Delivery Technologies (ADT)
Title: ADT Operations Technician (1st Shift)
Requisition ID: 0020417