Form and Fill Technician II - 1st shift

SUN PHARMA; Billerica (MA); On-site; USD 52,000 - 76,000; Full time

Job summary

SUN PHARMA is seeking a first shift manufacturing technician to formulate and dispense pharmaceutical products in a clean room under cGMP and SOPs. The role operates 6:00AM to 2:30PM EST, performing both automatic and manual processes and maintaining documentation for batch records.

Responsibilities include washing and sterilizing equipment, preparing glassware, following safety policies, and ensuring compliance with FDA regulations.

Qualifications

• High School Diploma or GED required.
• Work under direct supervision and follow clearly described procedures.
• Education in Life sciences or technical discipline is 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.
• Wash and sterilize all equipment and materials.
• Perform all manufacturing processes as needed.
• Clean manufacturing facility and equipment.
• Follow company safety policies.
• Prepare glassware and lab equipment for production.
• Document data and review batch records for specifications.
• Assist in SOP and batch record reviews.
• Monitor equipment under direction as needed.
• Complete paperwork to conform with FDA regulations.
• Other duties as assigned.

Skills

Attention to detail

Good organizational skills

Strong communication

Basic computer skills

Verbal and written communication

Education

High School Diploma or GED

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