Form & Fill Tech II

SUN PHARMA; Billerica (MA); On-site; USD 30,000 - 47,000; Full time

Job summary

SUN PHARMA is hiring for a 2nd shift position (1:30PM - 10:00PM) to formulate and dispense pharmaceutical products in a clean room under cGMP guidelines. The role involves operating and maintaining equipment, documenting batch records, and ensuring compliance with SOPs and FDA regulations.

Responsibilities include cleaning and sterilizing equipment, preparing glassware, and performing both automated and manual manufacturing tasks in a controlled environment.

Qualifications

• High School Diploma or GED required.
• Work under direct supervision and follow clearly described procedures.
• Education in Life sciences or technical discipline 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 and dermatological products.
• Wash and sterilize all equipment, tubing, filters, stoppers, vessels, vials and ampoules.
• Perform automatic and manual manufacturing processes as needed.
• Clean manufacturing facility and equipment as needed.
• Follow company policies relating to job safety.
• Prepare and set up glassware and lab equipment for production.
• Document data and review batch records to ensure specifications are met.
• Assist in review of SOPs and batch records as needed.
• Monitors equipment under direction as needed.
• Complete paperwork to conform with FDA regulations.
• Other duties as assigned.

Education

High School Diploma or GED

Life sciences/technical discipline education

Attention to detail

Strong verbal, written and interpersonal communication

Good organizational and record keeping skills

Basic computer skills

Ability to visually inspect small products/print

Tools

Lab equipment operation

cGMP training

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