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Job Description
SHIFT: This is a Night Shift Position
OBJECTIVES:
Perform and document daily manufacturing operations according to SOP’s in a Good Manufacturing Practices (cGMP) environment
Operate biologic production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)
Execute validation protocols
Create or revise cGMP documents
ACCOUNTABILITIES:
With general supervision or guidance will assemble and/or operate biologic production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
Perform basic trouble shooting
Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems
Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
Executes batch records and validation protocols under supervision/direction of others
Author and review equipment use logs
Performs inventory transactions in SAP
Performs data entry into LIMS
Accountable for completing assigned training within required timeline and actively participate in training activities.
Stock production and cleaning supplies
Perform cleaning/sanitizing production rooms and equipment
Other duties as assigned
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Preferred combination of education and experience:
Bachelor’s degree in Science or Engineering; or
Associate’s degree in science-related area and 1 or more years of relevant experience; or
High school diploma or GED and 3 or more years of relevant experience.
Experience in a regulated environment preferred
Knowledge, competencies and skills:
Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred
Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
Prior experience with lab equipment a plus
Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
Must have excellent written and oral communication skills
Must be team and detail-oriented and able to work in a fast-paced environment.
Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)
Must be able to read and understand English
LICENSES/CERTIFICATIONS:
N/A
PHYSICAL DEMANDS:
Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily
Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute duration while handling production equipment and/or materials
Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute duration
Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute duration
Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute duration
Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time
Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time
Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time
OTHER REQUIREMENTS:
Must have the ability to work assigned shift (day or night)
Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection
On rare occasions, travel may be required to offsite meetings or training even
