Manufacturing Tech lii Lead

PCI Services•Bedford, NH

64d

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. Summary of Objective: The Manufacturing Technician III/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.

Requirements

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 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 complexities and unexpected events, 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.
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
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