Manufacturing Technician III

Essential Duties and Responsibilities

• Maintains and adheres to safe work habits and all applicable PCI safety procedures and guidelines.
• Is proactive in identifying safety risks and alerts management to take corrective action.
• Mentors less experienced staff in the performance 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.
• Train peers and less experienced operators
• Troubleshoot and resolve problems with equipment or processes in the course of performing job duties
• 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
• Demonstrate general understanding of sanitization and sterilization practices (build, clean and sterilize equipment to support production operations
• 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

• 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

Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc. This is an individual contributor role TRAVEL – <10%

Qualifications

• 3 – 5 years of working experience in the pharmaceutical or medical device industry.
• Strong knowledge of aseptic techniques and fill finish experience required
• Experience in reviewing and creating controlled documents
• Requires a high school diploma with 4+ years of cGMP Pharmaceutical experience to include finished dose form
• Ability to weigh and measure raw materials and operate basic Benchtop instruments
• Strong ability to plan and prioritize complex activities to meet goals and objectives
• Strong analytical skills to identify risks and prepare balanced decisions
• Excellent organizational, verbal and written communication skills
• Detail oriented with strong mechanical aptitude
• Positive attitude and strong interpersonal skills to resolve and de-escalate issues.
• Honesty, integrity, respect and courtesy with leadership and peers
• Strong commitment 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
• Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.