Manufacturing Tech lII/IV Lead M-F First Shift

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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and

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.
• ◆Leads team to successfully and completely accomplish daily tasks
• ◆Maintains weekly/daily schedule up to date and provides direction to team
• ◆Accountable for completing daily tasks and reporting and escalating 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, 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, maintains and reviews documentation related to assigned work, including logbooks, batch records, etc.
• ◆Trains others on the team, and ensures proper training completion within the team prior to assigning tasks
• ◆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; perform investigations as needed
• ◆Maintains compliance, cleanliness and orderliness of operational areas per appropriate SOPs
• ◆Performs COP, CIP, and SIP operations to prepare equipment for manufacturing operations
• ◆Demonstrated 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: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• ◆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: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• ◆Interacts with cross functional support teams such as Operations, QA, QC, Engineering, R&D, Validation, etc.
• ◆Leads team of manufacturing technicians to complete scheduled activities
• ◆Raise any personnel related issues to management for resolution
• ◆Assigns daily tasks
• ◆TRAVEL –

The

listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• ✓2 – 4 years in the pharmaceutical or medical device industry finished dose form preferred
• ✓Strong knowledge of aseptic techniques and fill finish experience required
• ✓Experience in reviewing and creating controlled documents
• ✓Requires a high school diploma
• ✓Possesses the skill and aptitude to weigh and mea