Pharmaceutical Technician I
About the role
As a Pharmaceutical Technician at Ardena, you will contribute to pharmaceutical development projects by performing scientific, technical, or operational activities within a GMP-regulated environment. You will ensure that all work meets GMP, GxP, and applicable ISO standards while collaborating with cross-functional teams including Quality Assurance, Regulatory Affairs, Project Management, Production, and other departments across Ardena’s European and US sites.
This cross-functional position encompasses processes such as Dispensing, Milling, Blending, Granulation, Fluid Bed Coating, Compression, Encapsulation, and Tablet Coating. Key skills include Hot Melt Extrusion, Wet and Dry Granulation, Glatt Fluid Beds (Top spray, Bottom spray, and Drying), and Roller Compaction. You must maintain accurate records, understand batch records, and uphold cleanliness in the work area while following standard operating procedures.
Responsibilities
- Utilize dispensing systems (scales and balances) to accurately weigh, dispense, and label raw materials for manufacturing.
- Prepare partial raw material containers for return to the warehouse, deface, and dispose of empty raw material drums per SOPs.
- Verify the accuracy of materials delivered from the dispensing area and in-process materials from prior unit operations per SOPs.
- Perform duties related to milling, blending, and granulating drug products, including disassembly, cleaning, setup, and operation of relevant equipment.
- Execute compression and encapsulation processes, including disassembly, cleaning, setup, and operation of equipment such as Tablet Presses, Capsule Fillers, Dedusters, Metal Detectors, Disintegration Testers, Friabilators, and related systems.
- Perform film coating of drug products, including disassembly, cleaning, setup, and operation of Fluid Beds, Coating Pans, Solution Tanks, Spray Guns, and Mixers.
- Maintain a clean and safe work area, performing room and equipment cleanings as needed.
- Adhere to Health and Safety Regulations, Policies, and Procedures, as well as cGMPs and other regulatory requirements.
- Follow all SOPs, Batch Records, and Protocols, and use approved Personal Protective Equipment (PPE) as directed.
- Complete all required training activities and accurately document GMP-related tasks.
- Perform room and equipment inspections and complete associated documentation.
- Perform other duties as assigned.
Requirements
- High School Diploma or equivalent (required).
- 2+ years of prior experience in a pharmaceutical, biotech, or food manufacturing environment regulated by GMP standards (preferred).
- Specific experience in oral solid dosage manufacturing, including milling, blending, granulation, fluid bed, Hot Melt Extrusion, compression, capsule filling, or pan coating.
- Expertise in at least one manufacturing discipline, with optimal skills in Hot Melt Extrusion, Wet/Dry Granulation, Glatt Fluid Beds (Top spray, Bottom spray, and Drying), and Roller Compaction.
Skills
- Ability to assemble and disassemble machinery using hand tools.
- Proficiency in following instructions and procedures (SOPs, cGMPs).
- Strong safety awareness and adherence to protocols.
- Legible handwriting and proficient reading/comprehension skills.
- Strong leadership, decision-making, and technical/troubleshooting skills.
- High level of technical expertise and problem-solving ability.
- Exemplary leadership skills, including coaching, training, and mentoring team members.
- Mathematical and reasoning ability.
- Ability to interpret written, oral, diagrammatic, or scheduled instructions.
- Ability to work effectively under pressure to meet deadlines.
Physical Requirements
- Ability to sit, stand, walk, bend, kneel, crouch, and stoop regularly.
- Occasional lifting of 0-50 pounds.
- Ability to wear a respirator for several hours due to work with potent compounds.
- Accessibility to manufacturing floor and office staff, with frequent use of office equipment and computer monitors.
- Specific vision requirements for reading documents and operating equipment.
Work Environment
- Must wear safety glasses and other specified PPE in designated areas.
- Adherence to plant safety requirements, including OSHA-regulated fit-testing for air-purifying respirators.
- Training in hazardous material procedures and use of approved fall prevention devices for elevated tasks.
- Capability to wear steel-toed safety shoes for 8-12 hours per shift.
- Work environment is temperature- and humidity-controlled as needed for product integrity.
- Primary work area is in operations, where noise levels can be moderate to high; hearing protection may be required for certain tasks.
Benefits
- Competitive salary and tailored benefits package (adjusted per role and location).
- Flexible working arrangements and paid annual leave (where applicable).
- 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.
- Values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent.
Pay
Salary Range: $60,000 - $72,000 (DOE).