3rd Shift Pharmaceutical Technician 11pm - 7am

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.

Job Overview

Position: 3rd Shift Pharmaceutical Technician

Department: Operations

Location: Somerset (US)

This is a cross-functional position encompassing, but not limited to the Dispensing, Milling, Blending, Granulation, Hot Melt Extrusion, Fluid Bed Coating, Compression, Encapsulation, Tablet Coating manufacturing processes. Must be able to keep accurate and detailed records, understand batch records and maintain cleanliness of work area. Must follow standard operating procedures.

Role Description

This is a cross-functional position encompassing, but not limited to the Dispensing, Milling, Blending, Granulation, Hot Melt Extrusion, Fluid Bed Coating, Compression, Encapsulation, Tablet Coating manufacturing processes. Must be able to keep accurate and detailed records, understand batch records and maintain cleanliness of work area. Must follow standard operating procedures.

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.

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.

· Prior experience with the disassembly, cleaning, set-up and operation of various size hot melt extruders preferred.

· 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.

Required Qualifications:

• Education or Equivalent Requirements:

· High School diploma or equivalent (GED).

Experience:

· 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.

Knowledge/Skills Requi