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The Drug Product Manufacturing Technician learns and performs a variety of tasks with supervision and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirement and standards and following all safety guidelines of PCI. With supervision, the technician performs routine and critical manufacturing operations, including but not limited to work functions in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products. Works with Master production records and standard operating procedures. Conducts self in accordance with the Guardian values and behaviors.
Job Responsibility:
Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines
Demonstrates general knowledge of aseptic techniques
Prepares solutions, aseptic filling, and labeling of vials under sterile and non-sterile conditions, routine solution and filtration, vial and component preparation and sterilization
Assembles, disassembles, and operates aseptic filling equipment and lyophilizer equipment in classified cleanroom and controlled non classified environments
Operates vial capper, unloads product from lyophilizers and liquid fill line
Prepares equipment and components for sterilization and Lyophilization
Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation, centrifuges, mills equipment
Assists in the formulation and dispensing of product in a clean room environment per SOPs and MBRs
Sanitizes production areas and prepares equipment for production
Completes and maintain documentation related to assigned work, including logbooks, batch records, etc.
Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps
accurately completes appropriate production documentation
Identifies, escalates and documents events that deviate from normal operation
participate as needed in investigations
Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
Reviews and revises pertinent SOPs and production batch records as required
Inspire and constantly strive to make PCI a great place to work and respected for the quality of its people and products and clients
Successfully participates in media fill/aseptic proficiency test
Requirements:
0 – 2+ years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry
Minimum of a High school diploma/equivalency
Ability to weigh and measure raw materials and operate basic Benchtop instruments
Able to follow written instructions
Good verbal and written skills
Pay attention to detail
Demonstrates a good mechanical aptitude
Honesty, integrity, respect and courtesy with leadership and peers
Openly receives and implements feedback, resilient, able to move past mistakes
applies learning
Self-starter, able to work in a fast dynamic work setting
Ability to wear personal protective equipment
Ability to gown and gain entry to controlled manufacturing areas
Ability to lift, pull or push equipment requiring up to 25-50 lbs of force
Ability to stand for 6 hours in a production suite
Ability to work any shift (up to 10 hours) as required
Ability to adapt to a changing process daily
Able to work under the scrutiny of clients daily
Expected to be flexible with the process and adjust work hours accordingly