Form and Fill Technician II

This role is for first shift, 6:00 AM - 2:30 PM EST.

Responsibilities

• Formulate and dispense product in a clean room environment for radiopharmaceuticals as well as dermatological products.
• Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials, ampoules, etc.
• Perform all automatic and manual manufacturing processes as needed.
• Perform all required cleaning of manufacturing facility and equipment.
• Follow all company policies relating to job safety.
• Perform preparation and set-up of glassware and lab equipment to ensure proper conditions for production process.
• Document data and review completed batch records to ensure product is made in accordance with specifications.
• Assist in review of SOPs and batch records, as needed.
• Perform equipment monitoring, under direction, as needed.
• Complete all necessary paperwork to conform with FDA regulations.
• Other duties as assigned.

Work Conditions

• Office, lab, and controlled areas.
• Exposure to syringes and needles.

Physical Requirements

• Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch, or crawl.
• Talk and hear.
• Close vision, color vision, peripheral vision, depth perception, and ability to focus.
• Ability to visually inspect small products and print.
• Operate lab equipment and computers/office machines.
• Must wear lab coat and other safety attire.
• Lift up to 50 lbs.

Requirements

• High School Diploma or GED required.
• Work under direct supervision and follow clearly described procedures.
• Education in life sciences or technical discipline experience preferred.
• Good organizational and record-keeping skills.
• Basic computer skills.
• Attention to detail.
• Strong verbal, written, and interpersonal communication skills.
• Ability to visually inspect small products/print.
• Minimum of 2 - 5 years related experience preferred.
• Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs) preferred.
• Basic math, computer, and record-keeping skills required.
• cGMP training a plus.
• Familiarity with aseptic fill/finish, formulation techniques preferred.
• Experience working in a controlled environment preferred.
• Related experience in a pharmaceutical environment preferred.