Manufacturing Technician I Wed to Sat 6AM to 4:30 PM

Essential Duties and 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, 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.
• Successfully participates in media fill/aseptic proficiency test.

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 skills.
• Pay 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.