Manufacturing Technician II Job at PCI Pharma Services (Bedford)

Job Description

The Manufacturing Technician II proficiently performs a variety of complex tasks under general guidance 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
Proficient execution and 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 prepare 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

2-4 years of working experience, preferably in a manufacturing environment ideally in the pharmaceutical or medical device industry
Fill finish experience, preferred
Requires AA degree with 0-2 years’ experience or high school diploma with 1-3 years related manufacturing experience or associate degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Biotech Certificate and 1 year of experience
Attention to detail with good mechanical aptitude
Good attitude and good interpersonal skills
Honesty, integrity, respect and courtesy with leadership and peers
Demonstrates a commitment to conducting PCI business according to the highest legal and ethical standards
Resiliency, the ability to move forward despite mistakes, with a sincere desire to improve
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
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 dependent on business needs

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Manufacturing Technician II

Job Description

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