Sterile Manufacturing Operator, 3rd Shift
Houston, TX Houston, TX Full-time Full-time Estimated:
$38.
5K - $48.
7K a year Estimated:
$38.
5K - $48.
7K a year Position
Summary:
The Sterile Manufacturing Operator (SMO) is responsible for executing all processes related to the manufacture of sterile product at Empower's 503B facility.
Manufacturing personnel must adhere to 21 CFR parts 210/211 and USP / regulations, current Good Manufacturing Practices (cGMP), and department's Standard Operating Procedures (SOPs).
Shift 11:
00pm - 7:
00am Duties and
Responsibilities:
Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
Manufactures sterile product accurately and in compliance with master batch records while adhering to department specific SOPs.
Utilizes appropriate aseptic technique when performing tasks within the cleanroom.
Operates all fill-finish and ancillary manufacturing equipment in order to deliver quality medication.
Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance to approved procedures.
Assists with sterilization of components used in the manufacturing process.
Performs essential calculations and completes thorough documentation.
Methodically prepares work area and supplies prior to manufacturing.
Performs transfer of products from the cleanroom to the Inspection and Labeling team.
Becomes trained and qualified in the sterile operation via internal training program.
Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, autoclaving, bubble point testing, material preparation, inventory accounting, organization of components, and various LEAN manufacturing tasks (6S, GEMBA, Kaizen).
Performs other duties and responsibilities within the department to ensure timely execution of the production schedule.
Ensures all required hygienic practices and garbing are performed per company policy.
Achieves Gown Qualified status within two attempts, allowing entry into the cleanroom.
Observes and aids in coaching new hires on sterile operations.
Is dependable with attendance and is on-time for each shift start.
Provides overtime support, as needed, to maintain appropriate inventory levels.
Assist with special projects, as needed.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.
The requirements listed above are representative of the knowledge, skill, and/or ability required.
Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear.
The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices.
The employee is regularly required to move about the office and around the corporate campus.
The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Vision abilities required by this job include close vision.
Employee must be able to stand and walk for extended periods of time for consecutive days.
Knowledge and Skills:
Detail-oriented and self-motivated.
Work in a confined, controlled environment for extended periods of time (4 plus hours).
Must be able to work with hazardous substances (drugs) and work with strong odors (such as paracetic acid).
Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery.
Ability to carry out detailed written or oral instructions.
Must be able to fully gown in aseptic garb for extended periods of time.
Must pass gowning sampling within two attempts for entry into the cleanroom.
Must be able to perform rudimentary mathematical calculations as related to compounding or manufacturing processes.
Must be able to stand and walk for extended periods of time for consecutive days.
Must be able to lift up to 30 lbs.
Experience and
Qualifications:
High School Diploma or equivalent required.
Previous manufacturing experience preferred.
Previous cGMP or LEAN manufacturing experience preferred.
Experience with operation of equipment and/or tools preferred.
Detail-oriented and self-motivated.
Work in a confined, controlled environment for extended periods of time (4 plus hours).
Must be able to fully gown in aseptic garb for extended periods of time.
Must be able to work with hazardous substances (drugs) and work with strong odors (such as, but not limited to, peracetic acid).
Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery.
Ability to carry out detailed written or oral instructions.
Must be able to perform rudimentary mathematical calculations.
Benefits:
Health/Vision/Dental Insurance 401k with company matching Paid Time Off (PTO) Volunteer Time Off (VTO) Paid Holidays.
Estimated Salary: $20 to $28 per hour based on qualifications.
$38.
5K - $48.
7K a year Estimated:
$38.
5K - $48.
7K a year Position
Summary:
The Sterile Manufacturing Operator (SMO) is responsible for executing all processes related to the manufacture of sterile product at Empower's 503B facility.
Manufacturing personnel must adhere to 21 CFR parts 210/211 and USP / regulations, current Good Manufacturing Practices (cGMP), and department's Standard Operating Procedures (SOPs).
Shift 11:
00pm - 7:
00am Duties and
Responsibilities:
Performs sterile manufacturing in a cGMP cleanroom environment (ISO 5, ISO 7, ISO 8).
Manufactures sterile product accurately and in compliance with master batch records while adhering to department specific SOPs.
Utilizes appropriate aseptic technique when performing tasks within the cleanroom.
Operates all fill-finish and ancillary manufacturing equipment in order to deliver quality medication.
Maintains an ISO classified environment through rigorous cleaning and disinfecting of the cleanroom in accordance to approved procedures.
Assists with sterilization of components used in the manufacturing process.
Performs essential calculations and completes thorough documentation.
Methodically prepares work area and supplies prior to manufacturing.
Performs transfer of products from the cleanroom to the Inspection and Labeling team.
Becomes trained and qualified in the sterile operation via internal training program.
Performs ancillary tasks and duties that support the manufacturing process such as, but not limited to, autoclaving, bubble point testing, material preparation, inventory accounting, organization of components, and various LEAN manufacturing tasks (6S, GEMBA, Kaizen).
Performs other duties and responsibilities within the department to ensure timely execution of the production schedule.
Ensures all required hygienic practices and garbing are performed per company policy.
Achieves Gown Qualified status within two attempts, allowing entry into the cleanroom.
Observes and aids in coaching new hires on sterile operations.
Is dependable with attendance and is on-time for each shift start.
Provides overtime support, as needed, to maintain appropriate inventory levels.
Assist with special projects, as needed.
To perform this job successfully, an individual must be able to perform each essential function satisfactorily.
The requirements listed above are representative of the knowledge, skill, and/or ability required.
Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
While performing the responsibilities of the job, the employee is required to talk and hear.
The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices.
The employee is regularly required to move about the office and around the corporate campus.
The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
Vision abilities required by this job include close vision.
Employee must be able to stand and walk for extended periods of time for consecutive days.
Knowledge and Skills:
Detail-oriented and self-motivated.
Work in a confined, controlled environment for extended periods of time (4 plus hours).
Must be able to work with hazardous substances (drugs) and work with strong odors (such as paracetic acid).
Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery.
Ability to carry out detailed written or oral instructions.
Must be able to fully gown in aseptic garb for extended periods of time.
Must pass gowning sampling within two attempts for entry into the cleanroom.
Must be able to perform rudimentary mathematical calculations as related to compounding or manufacturing processes.
Must be able to stand and walk for extended periods of time for consecutive days.
Must be able to lift up to 30 lbs.
Experience and
Qualifications:
High School Diploma or equivalent required.
Previous manufacturing experience preferred.
Previous cGMP or LEAN manufacturing experience preferred.
Experience with operation of equipment and/or tools preferred.
Detail-oriented and self-motivated.
Work in a confined, controlled environment for extended periods of time (4 plus hours).
Must be able to fully gown in aseptic garb for extended periods of time.
Must be able to work with hazardous substances (drugs) and work with strong odors (such as, but not limited to, peracetic acid).
Communicate and collaborate effectively with a team to achieve goals around safety, quality, and delivery.
Ability to carry out detailed written or oral instructions.
Must be able to perform rudimentary mathematical calculations.
Benefits:
Health/Vision/Dental Insurance 401k with company matching Paid Time Off (PTO) Volunteer Time Off (VTO) Paid Holidays.
Estimated Salary: $20 to $28 per hour based on qualifications.
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