3rd Shift Pharmaceutical Technician 11pm - 7am

Ardena • Franklin Township, NJ

6d • Onsite

About The Position

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market. The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

Requirements

• High School diploma or equivalent (GED).
• 3+ years working in a pharmaceutical, biotech or food manufacturing environment (regulated by GMP standards and requirements); 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 three manufacturing disciplines.
• 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 with the disassembly, cleaning, set-up and operation of various size hot melt extruders preferred.

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 a plus.
• 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.
• 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.
• Will maintain the immediate work area in a clean and safe manner and perform room and equipment cleanings as needed.
• 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

• Competitive salary and tailored benefits package (adjusted per role and location)
• Flexible working arrangements and paid annual leave (where applicable, depending on role and site)
• International and collaborative work environment across European and US sites
• Access to professional development and training programs
• Meaningful work on pharmaceutical development projects that advance patient health

What This Job Offers

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