Pharmaceutical Technician I, 2nd Shift

Ardena • Somerset, NJ

6d • Onsite

About The Position

Ardena is a leading Contract Development and Manufacturing Organization (CDMO) partnering with pharmaceutical companies of all sizes to navigate drug development with precision, quality, and speed. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a growing international footprint, Ardena has over 750 professionals across six strategic locations. Our culture is built on collaboration, ownership, and innovation, guided by our We CARE values, fostering a communicative environment of mutual respect, accountability, and excellence. We are seeking skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Ardena provides a dynamic workplace for personal and professional growth, contributing to meaningful drug development projects and making a difference in the future of medicine. For the Ardena Business Unit based in Somerset (US), we are looking for Pharmaceutical Technicians for our 2nd shift.

Requirements

• High School Diploma or equivalent is required.
• 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 handwriting skills.
• Proficient reading and comprehension skills.
• Strong leadership skills.
• Strong decision-making skills.
• Technical skills/trouble shooting skills.
• Demonstrate a high level of technical expertise and problem solving skills.
• Exemplary leadership skills, demonstrate the ability to lead project team (coach, train, mentor team members).
• Mathematical and reasoning ability.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under pressure to meet deadlines.
• Individual may be required to sit, stand, walk regularly.
• Individual may be required to bend, kneel, crouch, and stoop.
• Occasionally lift 0-50 pounds.
• Individual may be required to wear a respirator for several hours at a time due to work associated with potent compounds.
• Be accessible to manufacturing floor and office staff and to use required office equipment.
• Specific vision requirements include reading of written documents and frequent use of computer monitor.
• Must wear safety glasses, in addition to other specified PPE, in all designated areas.
• Must follow any applicable plant safety requirements.
• Must be fit-tested as per OSHA regulations, trained and capable of wearing air purifying respirator.
• Must be trained in plant hazardous material procedures.
• Must use approved fall prevention devices when performing elevated tasks.
• Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift.

Nice To Haves

• Prior experience working in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements for at least 2 years) is preferred; with specific experience in oral solid dosage manufacturing (milling, blending, granulation, fluid bed, Hot Melt Extrusion, compression, capsule filling or pan coating manufacturing processes).
• Expert in at least one manufacturing discipline.

Responsibilities

• Utilizing the current dispensing systems of scales and balances, accurately weigh/dispense and label raw materials for manufacturing.
• Accurately prepares for return to the warehouse all partial raw material containers, defaces and disposes of all empty raw material drums as per current SOP’s.
• Checks for accuracy all materials delivered from the dispensing area as well as all in-process materials from the prior unit operation as per current SOP.
• Performs all the duties necessary to mill, blend and granulate drug products which includes the disassembly, cleaning, set-up and operation of milling, blending and granulation manufacturing equipment.
• Performs all the duties necessary to compress and encapsulate drug products, which includes the disassembly, cleaning, set-up and operation of manufacturing equipment such as but not limited to Tablet Presses, Capsule Fillers, Dedusters, Metal Detectors, Disintegration Testers, Friabilators, Tablet and Capsule In Process Weight Check Systems, Hardness Testers and Micrometers.
• Performs all the duties necessary to film coat drug products, which includes the disassembly, cleaning, set-up and operation of manufacturing equipment such as but not limited to various size Fluid Beds, Coating Pans, Solution Tanks, Spray Guns and Mixers.
• Will maintain the immediate work area in a clean and safe manner and perform room and equipment cleanings as needed.
• Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
• Comprehends and adheres to all cGMP’s and other Regulatory requirements.
• Comprehends and adheres to all related SOP’s as well as Batch Records and Protocols.
• Required to use all approved and issued Personal Protective Equipment as directed by policy and procedure.
• Completes all required training activities.
• Clearly and accurately completes all required GMP documentation.
• Perform room and equipment inspections and completes all pertinent documentation.
• Other duties as assigned.

Benefits

• medical, dental and vision benefits effective day one of employment
• Paid Time Off
• A dynamic, global work environment with career growth opportunities
• Access to Ardena Academy, our internal learning platform for professional development
• A chance to contribute to groundbreaking drug development projects that make a real impact

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED