More jobs:
Drug Product Manufacturing Technician I/II/II M-F
Job in
Madison, Dane County, Wisconsin, 53774, USA
Listed on 2026-07-13
Listing for:
PVH (Tommy Hilfiger/Calvin Klein)
Full Time
position Listed on 2026-07-13
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Manufacturing & Industrial Operations, Production Associate / Production Line, Validation Engineer
Job Description & How to Apply Below
Job Overview
The Manufacturing Technician I learns and performs a variety of tasks with supervision in accordance with manufacturing instruction sets, GMP/ISO requirements, and PCI safety guidelines. The technician handles routine and critical manufacturing operations for biopharma and medical device products, including equipment preparation, formulation, aseptic compounding, filling, labeling, and documentation.
Responsibilities- Maintain safe work habits and adhere to PCI safety procedures and guidelines.
- Demonstrate general knowledge of aseptic techniques.
- Prepare solutions, perform aseptic filling, and label vials under sterile and non‑sterile conditions.
- Execute routine solution and filtration, vial and component preparation, and sterilization.
- Assemble, disassemble, and operate aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled environments.
- Operate vial capper, unload product from lyophilizers and liquid fill lines.
- Prepare equipment and components for sterilization and lyophilization.
- Operate processing equipment such as autoclaves, ovens, vial washers, depyrogenators, centrifuges, and mills.
- Assist in formulation and dispensing of product in a clean room environment per SOPs and MBRs.
- Sanitize production areas and prepare equipment for production.
- Complete and maintain documentation, including logbooks and batch records.
- Adhere to verbal and written instructions when operating production equipment and performing processing steps.
- Identify, escalate, and document events that deviate from normal operation; participate in investigations as needed.
- Maintain cleanliness, cleanliness, and orderliness of operational areas per SOPs.
- Perform COP, CIP, and SIP operations to prepare equipment for manufacturing.
- Review and revise pertinent SOPs and production batch records as required.
- Successfully participate in media fill/aseptic proficiency tests.
The role involves interaction with cross‑functional support teams such as Operations, QA, QC, Engineering, R&D, and Validation. This is an individual contributor position that requires flexibility and adaptation to daily process changes and variable client products.
Physical Demands- Wear personal protective equipment (safety glasses/goggles, gloves, safety shoes).
- Gown and gain entry to controlled manufacturing areas.
- Lift, pull, or push equipment requiring up to 25–50 lbs of force.
- Stand for up to 6 hours in a production suite.
- Work any shift (up to 10 hours) as required depending on business needs.
- 0–2 years of experience, preferably in a manufacturing environment within the pharmaceutical or medical device industry.
- High school diploma or equivalent.
- Ability to weigh and measure raw materials and operate basic benchtop instruments.
- Follow written instructions and seek help when needed.
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