Formulation and Fill Technician I - 2nd Shift

Sun Pharmaceutical Industries; Billerica (MA); Presencial; USD 30.000 - 39.000; Jornada completa

Descripción de la vacante

Sun Pharmaceutical Industries is seeking a production/dispensing technician for the second shift (1:30PM-10PM EST). The role supports formulation and dispensing in a clean room, adhering to cGMP and SOP guidelines.

Responsibilities include equipment sterilization, data documentation, batch record reviews, and FDA compliance paperwork. Candidates should have a High School Diploma or GED and strong attention to detail, with basic computer skills and solid written and verbal communication.

Formación

• High School Diploma or GED required.
• Good organizational and record keeping skills.
• Attention to detail and accuracy in documentation.
• Strong verbal, written and interpersonal communication skills.
• Basic computer skills for data entry and record keeping.
• Familiarity with SOPs and cGMP standards a plus.
• Experience following established SOPs and master batch records.

Responsabilidades

• Formulate and dispense product in a clean room environment for Radio-pharm and dermatological products.
• Wash and sterilize all equipment, tubing, filters, stoppers, vessels and vials.
• Perform all automatic and manual manufacturing processes as needed.
• Perform all required cleaning of manufacturing facility and equipment as needed.
• Document data and review batch records to ensure compliance with specifications.
• Assist in review of SOPs and batch records as needed.
• Complete paperwork to conform with FDA regulations.
• Other duties as assigned.

Conocimientos

Attention to detail

Record keeping

Verbal communication

Written communication

Basic computer skills

SOP literacy

cGMP knowledge

Educación

Life sciences background preferred

High School Diploma or GED

Descripción del empleo

Job Summary

This role is for second shift 1:30PM-10PM 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