Pharmaceutical Technician Job Clifton area,New Jersey USA,Manufacturing / Production

Position: Pharmaceutical Technician I

About Ardena

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. Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support. Ardena is hiring a Pharmaceutical Technician I to join the Operations team at our Somerset site. This role supports pharmaceutical development and manufacturing activities within a GMP-regulated environment.

Role Description

As a Pharmaceutical Technician at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within the [Department]. You will work in a regulated pharmaceutical environment, ensuring that all work meets GMP, GxP, and applicable ISO standards.

You will collaborate with cross-functional teams including Quality Assurance, Regulatory Affairs, Project Management, Production, and other departments across Ardena’s European and US sites.

What You Will Work On YOUR ROLE

This is a cross-functional position encompassing, but not limited to the Dispensing, Milling, Blending, Granulation, Fluid Bed Coating, Compression, Encapsulation, Tablet Coating manufacturing processes.
Specifically, optimal skills would be
- Hot Melt Extrusion, Wet and dry granulation, Glatt Fluid Beds, (Top spray, bottom spray and drying), Roller Compaction. Must be able to keep accurate and detailed records, understand batch records and maintain cleanliness of work area. Must follow standard operating procedures.

Your

Key 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.
Complet…