Job Description

Job Title

Manufacturing Operator

Requisition

JR000015833 Manufacturing Operator (Open)

Location

US NJ Cranbury - USA704

Additional Locations

The Manufacturing Operator will perform duties assigned in production areas for the manufacture and packaging of finished drug products. This role will maintain the clean rooms, packaging room and equipment used in the manufacturing of drug products. Incumbent will be working in class 10,000 production rooms in a cGMP manufacturing area. This role will be required to produce and manufacture drug products according to specifications and batch record requirements by using appropriate machinery, equipment and materials. Perform environmental monitoring in clean rooms.

Manufacturing Operator must be able to read / write, follow written / oral instructions, read / understand SOP’s, Work instructions, cGMP policies and possess general computer skills. This position reports to the Mfg. Supervisor.

Key Accountabilities

Manufacturing

• Performs all tasks related to the manufacture and packaging of finished drug products independently.
• Executes and documents master batch formulas and logbooks at the highest level of cGMP compliance independently.
• Successfully performs the master formulas independently to complete the training process.
• Participates in investigations and root cause analysis as needed.
• Performs monomer/cartridge production, blending/pellet production and implant production.
• Sterilizes primary packaged drug products in steam autoclave.
• Performs ampule labeling operations.
• Performs primary packaging of drug product using only approved components.
• Assists in ordering production supplies and maintaining proper inventory.
• Performs all operations safely following all site safe work practices and procedures.
• Reports any unsafe acts or conditions immediately to the Operations Management.
• Prepares components and supplies for primary and secondary packaging operations.
• Packs bulk drug products into appropriate primary container closure system.
• Packs drug products into appropriate secondary packaging container/shippers.

Manufacturing Support

• Participates in clean room and equipment maintenance.
• Performs environmental monitoring in clean rooms.
• Participates in process and cleaning validation activities as required.

Qualifications

Education & Experience

• High School Diploma or equivalent is required.
• Minimum 2-4 years’ experience working in a cGMP manufacturing facility, preferably in a clean room environment.
• Minimum 2-4 years’ experience operating pharmaceutical manufacturing, packaging or labeling equipment.

Knowledge

• Knowledge of cGMP regulations.
• Must be able to read / write, follow written / oral instructions and read / understand Master Formulas, work instructions, and SOP’s.
• Knowledge of workplace health and safety requirements for applicable hazardous substances.

Skills & Abilities

• Ability to work in a team environment.
• Ability to follow instructions.
• Good communication skills.
• Ability to perform machine set-up, adjustments and operations.
• Possess general computer skills.
• Ability to interact with other departments.

Physical Requirements

• Ability to work overtime when required.
• Ability to wear respirators and other protective equipment.
• Ability to wear cleanroom garments and work in a class 10,000 production rooms.
• This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.
• Must have 20/20 Corrective vision. Any exception to 20/20 corrective vision is allowed by approval from manufacturing and quality management.

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova

The expected base pay range for this position is $52K - $63K Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

#LI-GN1

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com