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 is a cross-functional position encompassing the following manufacturing processes: Dispensing, Milling, Blending, Granulation, Fluid Bed Coating, Compression, Encapsulation, and Tablet Coating. Specific skills in Hot Melt Extrusion, Wet and Dry Granulation, Glatt Fluid Beds (Top spray, Bottom spray, and Drying), and Roller Compaction are highly valued. 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 manufacturing equipment.
- Execute compression and encapsulation of drug products, 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.
- Use approved Personal Protective Equipment (PPE) as directed by policy and procedure.
- Complete all required training activities.
- Accurately complete all required GMP documentation.
- Perform room and equipment inspections and complete pertinent 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 (milling, blending, granulation, fluid bed, Hot Melt Extrusion, compression, capsule filling, or pan coating) is highly valued.
- Expertise in at least one manufacturing discipline.
- Optimal skills: Hot Melt Extrusion, Wet and Dry Granulation, Glatt Fluid Beds (Top spray, Bottom spray, and Drying), Roller Compaction.
Skills
- Ability to utilize hand tools for assembling and disassembling machinery.
- Ability to follow instructions and procedures (SOPs, cGMPs).
- Strong attention to safety in the workplace.
- 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 instructions in written, oral, diagram, or schedule form.
- Ability to work effectively under pressure to meet deadlines.
Physical Requirements
- Ability to sit, stand, walk, bend, kneel, crouch, and stoop regularly.
- Occasionally lift 0-50 pounds.
- Ability to wear a respirator for several hours at a time due to work with potent compounds.
- Accessibility to the manufacturing floor and office staff, with frequent use of office equipment.
- Specific vision requirements include reading written documents and using a computer monitor.
Work Environment
- Must wear safety glasses and other specified PPE in designated areas.
- Must follow plant safety requirements and be trained in hazardous material procedures.
- Must be fit-tested per OSHA regulations and capable of wearing an air-purifying respirator.
- Must use approved fall prevention devices for elevated tasks.
- Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day.
- Work environment is temperature and humidity-controlled as needed for product.
- Primary work area is in operations, where noise levels can be moderate to high; hearing protection may be required for certain operations.
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).