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The Manufacturing Technician IV leads 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 leads and 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. Addresses 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, reviews and revises master production records and standard operating procedures. Trains and guides less experienced personnel. Is a model of the Guardian values and behaviors.
Job Responsibility:
Leads team to accomplish daily tasks
Maintains weekly/daily schedule up to date and provides direction to team
Accountable for completing daily tasks and reporting issues to management
Works with management to provide a positive culture within operations
Mentors less experienced staff in the performance of aseptic techniques
Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions
Assembles, disassembles and operates aseptic filling equipment and lyophilizer equipment
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
Sanitizes production areas and prepare equipment for production
Completes, maintains and reviews documentation related to assigned work
Trains and ensures proper training within the team prior to assigning tasks
Troubleshoot and resolve problems with equipment or processes
Adheres to verbal instructions and written procedures
Identifies, escalates and documents events that deviate from normal operation
Maintains compliance, cleanliness and orderliness of operational areas
Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
Demonstrated understanding of sanitization and sterilization practices
Inspire and constantly strive to make PCI a great place to work
Successfully participates in media fill/aseptic proficiency test
Requirements:
High school diploma with 4+ years of cGMP Pharmaceutical experience to include finished dose form
4+ 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
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 business according to the highest legal and ethical standards
Resilient, can quickly move forward despite challenges
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment
Exceptional organizational skills and attention to detail
Excellent interpersonal skills
Proficiency in MS Office including Word, and Excel
Ability to work in a dynamic, fast paced work environment
Creative with the ability to work with minimal supervision
Resilient through operational and organizational change
Ability to weigh and measure raw materials and operate basic benchtop instruments
Strong ability to plan and prioritize complex activities
Strong analytical skills to identify risks and prepare balanced decisions
Excellent organizational, verbal and written communication skills
Ability to wear personal protective equipment
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
Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
Requires the ability to communicate effectively using speech, vision, hearing and written word