Manufacturing Technician I

About the role

As a Manufacturing Technician I at PCI, you will learn and perform a variety of tasks with supervision, adhering to manufacturing instruction sets inclusive of current GMP/ISO requirements and standards, while following all safety guidelines. This role involves routine and critical manufacturing operations in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products.

Responsibilities

• 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, including 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, depyrogenation, centrifuges, and 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 maintains documentation related to assigned work, including logbooks and batch records.
• 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; participates 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.
• Successfully participates in media fill/aseptic proficiency tests.
• Commits to conducting PCI business according to the highest legal and ethical standards.

Special Demands

• 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.

Qualifications

• 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; seeks help with more complex and non-routine tasks.
• Good verbal and written communication skills.
• Attention to detail and demonstrated mechanical aptitude.
• Honesty, integrity, respect, and courtesy with leadership and peers.
• Openly receives and implements feedback; resilient and able to move past mistakes; applies learning.
• Self-starter, able to work in a fast-paced, dynamic work setting.