Pharmaceutical Techn

What You Will Work On

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

Key Responsibilities

• 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.

Profile

• Education and Experience:
• A High School Diploma or equivalent is required.
• 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. - Optimal skills would be - Hot Melt Extrusion, Wet and dry granulation, Glatt Fluid Beds, (Top spray, bottom spray and drying), Roller Compaction.
• Knowledge/Skills:
• 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.
• Physical Requirements:
• 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.

What We Offer

• A competitive salary with a tailor-made benefits package, including: 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.

Schedule

• First Shift

Benefits

• Medical
• Dental
• Vision

Salary Range

$60,000 - $72,000

How to Apply

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!

Department

Production

Role

Technician

Locations

Somerset (New Jersey, US)