Form & Fill Tech II - 2nd Shift

Sun Pharmaceutical Industries; Billerica (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Sun Pharmaceutical Industries in Massachusetts seeks a 2nd shift formulation and dispensing technician to operate in a clean room, following cGMPs and SOPs. You will prepare and dispense products for radio-pharm and dermatological uses, and ensure strict adherence to batch records and safety policies.

Responsibilities include glassware setup, equipment sterilization, and thorough documentation. Strong attention to detail and communication are essential in a team-driven environment with FDA

Qualifications

• High School Diploma or GED required.
• Follow clearly described procedures under supervision.
• 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.

Responsibilities

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

Skills

Attention to detail

Verbal and written communication

Record keeping

Basic computer skills

Education

High School Diploma or GED

Life sciences / technical discipline experience preferred

Job description

Job Summary

This position is for 2nd shift 1:30PM - 10PM

Performs the formulation and dispensing of pharmaceutical products according to current Good Manufacturing Practices (cGMPs) and utilizing Standard Operating Procedures (SOPs) in a clean room environment.

Area Of Responsibility

• Formulate and dispense product in a clean room environment for Radio-pharm 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 as needed
• 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
• 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/hear
• Close vision, color vision, peripheral vision, depth perception, ability to focus
• Ability to visually inspect small products and print
• Operate lab equipment
• Operate computers/office machines
• Must wear lab coat and other safety attire
• Lift up to 50 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• 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 inspection small products/print

Experience

• 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 pharmaceutical environment preferred