Rapid Micro Biosystems Automation Production Operator in Lowell, Massachusetts
The manufacturing cleanroom automation operator is a critical manufacturing role that ensures the safe operation of the automation line to meet target OEE conditions and deliver a quality product to our customers.
The cleanroom automation operator will fulfill manufacturing job responsibilities in a cleanroom environment (ISO 8) and will also carry out line cleaning, machine/process set up, web line set up and basic maintenance tasks related to the automation line.
ROLE AND RESPONSIBILITIES
Works safely according to company and OSHA guidelines.
Follows quality guidelines (Work Instructions) and effectively completes all required documentation.
Performs machine set up, cleaning, and basic maintenance of complex automation line for the production of cell culture cassettes.
Utilize HMI to make machine adjustments.
Monitor and react to multiple simultaneous machine sub-operations (for example: filling, webline, laser-cut, heat weld).
OTHER DUTIES AND RESPONSIBILITIES
Performs and enforces aseptic techniques while following the SOPs for the filling operation.
In conjunction cross-functional teams - work collaboratively to reinvestigate failures and perform CAPA investigations.
Assist as necessary to complete validations in a timely manner ensuring all relevant paperwork is completed.
Works on continuous improvement efforts as directed.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
Education: Associates degree, vocational tech training or relevant work experience (3+ years)
Knowledge/Experience (Nice to have):
Aseptic process/laboratory skills
1+ year of working cleanroom experience.
Knowledge of robotic systems
Working knowledge of EH&S, cGMP, and ISO guidelines. Familiarity with FDA regulations a plus.
Proven skills (must have):
Relevant manufacturing work experience (automation, clean room, aseptic products, etc.)
Ability to shift work schedule for periods as needed. Possibly working 4 day/10 hour schedule or 5 day/8 hour schedule within the hours of 5:30 am to 7 pm (shift structure is to be determined).
Must be able to communicate in English with others related to daily operations.
Good problem solving, math skills, and the ability to do mathematical conversions (Metric to English).
Good mechanical aptitude and skills.
Ability to work in a team environment
WORKING CONDITIONS/PHYSICAL DEMANDS
Appropriate gowning procedures will be required (hairnet, safety glasses, cleanroom apparel/lab coats, gloves)
Occasional environmental odors may be present
May be required to work extended hours and weekends on occasion
Must be able to lift 50 pounds
Rapid Micro Biosystems creates, sells, validates and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.
The company?s Growth Directthe first and only growth-based system to automate rapid compendial QC Micro testing?ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.
Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
Rapid Micro Biosystems is headquartered in Lowell, Massachusetts, with operations in Lowell and Freising, Germany.
Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.
Please no phone calls or agencies please.