Manufacturing Technician III

PCI Pharma Services • Madison, WI

4h

About The Position

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. Manufacturing Technician III mentors others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirements and standards and following all safety Guidelines of PCI. With general supervision, the technician performs all manufacturing operations including but not limited to work functions in equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging activities for biopharma and medical device products. Possess the ability to address non routine matters. Utilizes technical knowledge and experience to resolve complex manufacturing problems. Monitors personnel interaction to ensure proper behaviors. Escalates matters requiring resolution by management. Works with Master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of 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 basic 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. 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%

Requirements

• 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.
• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED