Manufacturing Technician Job at PCI Pharma Services (Bedford)

Job Description

The 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
Assembles, disassembles, and operates aseptic filling equipment and lyophilizer equipment
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
Adheres to verbal instructions and written procedures in operating production equipment and performing processing steps
Identifies, escalates and documents events that deviate from normal operation
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
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
Commits to conducting PCI business according to the highest legal and ethical standards
Honesty, integrity, respect and courtesy with leadership and peers
Openly receives and implements feedback, resilient, able to move past mistakes
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

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