Formulation and Fill Technician II - 1st shift

Sun Pharmaceutical Industries; Billerica (MA); On-site; USD 45,000 - 65,000; Full time

Job summary

Sun Pharmaceutical Industries seeks a Manufacturing Technician for first shift (6:00AM - 2:30PM EST) to formulate and dispense products in a clean room under cGMPs and SOPs.

The role includes aseptic fill/finish, preparing glassware, documenting batch records, and maintaining FDA-compliant operations in a controlled environment. A high school diploma and SOP/GMP familiarity are expected.

Qualifications

• High School Diploma or GED required.
• Experience following SOPs and batch records in a cGMP environment.
• Education in life sciences or technical discipline preferred.
• Strong organizational and record-keeping skills.
• Basic computer skills.
• Attention to detail and strong communication.
• Able to visually inspect small products/prints.
• Familiarity with aseptic fill/finish and formulation techniques preferred.

Responsibilities

• Formulate and dispense product in a clean room environment for Radio-pharm and dermatological products.
• Wash and sterilize equipment and components.
• Perform automatic and manual manufacturing processes as needed.
• Document data and review batch records to ensure conformance with specs.
• Assist in review of SOPs and batch records as needed.
• Complete paperwork to comply with FDA regulations.
• Operate and monitor equipment as directed.
• Follow safety policies and procedures.

Skills

Attention to detail

Verbal communication

Written communication

Interpersonal skills

Record keeping

Math skills

Computer skills

cGMP awareness

Education

High School Diploma or GED

Life sciences or technical discipline education preferred

Job description

Job Summary

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