Manufacturing Technician III/Lead Wed to Sat 3:30 PM to 2AM

The Manufacturing Technician III/IV leads others in a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set, including current GMP/ISO requirements and standards and PCI safety guidelines. With general supervision, the technician leads and performs manufacturing operations including equipment prep, dispensing, dissolution, formulation, purification, aseptic compounding, filling and packaging for biopharma and medical device products. The role addresses non-routine matters, resolves complex manufacturing problems, trains and guides less experienced personnel, and escalates matters requiring management resolution.

Responsibilities

Maintains and adheres to safe work habits and PCI safety procedures; Leads team to complete daily tasks; Maintains weekly/daily schedule and provides direction to team; Accountable for completing daily tasks and escalating issues to management; Mentors less experienced staff in aseptic techniques; Prepares solutions, aseptic filling and labeling of vials under sterile and non-sterile conditions; Assembles, disassembles and operates aseptic filling and lyophilizer equipment in classified cleanroom environments; Prepares equipment and components for sterilization and lyophilization; Operates processing equipment including autoclaves, ovens, vial washers, depyrogenation equipment, centrifuges and mills; Assists in formulation and dispensing of product per SOPs and MBRs; Sanitizes production areas and prepares equipment for production; Completes, maintains and reviews documentation including logbooks and batch records; Trains team members and ensures training completion before assigning tasks; Troubleshoots and resolves equipment and process problems; Identifies, escalates and documents deviations and performs investigations as needed; Maintains compliance, cleanliness and orderliness of operational areas; Performs COP, CIP and SIP operations; Successfully participates in media fill/aseptic proficiency tests; Works with, reviews and revises master production records and standard operating procedures

Requirements

2-4 years in the pharmaceutical or medical device industry; Strong knowledge of aseptic techniques and fill finish experience; Experience in reviewing and creating controlled documents; High school diploma; Skill and aptitude 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; 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; Commitment to conducting business according to the highest legal and ethical standards; Resilient, able to move forward despite complexities and unexpected events; Able to work as a self-starter and handle multiple priorities in a dynamic cross-functional team environment; 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 by business needs

Nice to have

Finished dose form experience preferred