MANUFACTURING TECHNICIAN l

4 weeks ago

Bedford, United States PCI Pharma Services Full time

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. Summary of Objective: 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. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. 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 Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. 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. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc. This is an individual contributor role. TRAVEL –

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