MANUFACTURING TECHNICIAN I/II/III

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Manufacturing Technician I 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.

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 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

• Ability to weigh and measure raw materials and operate basic Benchtop instruments
• Able to follow written instructions. Seeks help with more complex and non-routine tasks
• Good verbal and written skills
• 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.
• Pays attention to detail. Demonstrates a good mechanical aptitude.
• Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services
• 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 such as safety glasses / goggles, gloves and safety shoes.
• 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
• Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
• This is an individual contributor role

SPECIAL NOTE :

While the PCIMfg. Technician roles are essentially the same at all company pharmaceutical manufacturing sites, presently at 25 Commerce Drive Bedford, the extensive product mix creates a highly dynamic, complex and at times a challenging work environment.

Thus operators are expected to be highly resilient and possess the following skills an attributes :

• Ability to adapt to a changing process daily (i.e. Formulations vary depending on client product)
• Able to work under the scrutiny of clients daily
• Expected to be flexible with the process and adjust work hours accordingly

LI-HA1

Join us and be part of building the bridge between life changing therapies and patients.