Form & Fill Tech II - 2nd Shift

Sun Pharmaceutical Industries, Inc.; Billerica (MA); On-site; USD 34,000 - 44,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc (USA) is seeking a manufacturing technician for the 2nd shift (1:30 PM – 10:00 PM) to formulate and dispense pharmaceutical products in a clean room following cGMP and SOPs.

The role involves operating in a controlled environment for radio-pharm and dermatological products, performing equipment setup, data documentation, batch record review, and adherence to FDA regulations. Training in aseptic practices is preferred.

Qualifications

• High School Diploma or GED required.
• Supervised work under clearly described procedures.
• Education in Life sciences or technical discipline preferred.
• Good organizational and record keeping skills.
• Basic computer skills.
• 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 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

Skills

Communication skills

Record keeping

Basic computer skills

Attention to detail

Education

High School Diploma or GED

Job description

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Company: Sun Pharmaceutical Industries, Inc (USA)

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 computers/office machines
• Must wear lab coat and other safety attire
• Lift up to 50 lbs.

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
• 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