Sterile Operator

SUMMARY:

The Sterile Operator plays a vital role in our team, responsible for cGMP-compliant production and aseptic processing of sterile products in controlled cleanroom environments within a 503B outsourcing facility. The position requires strict adherence to cGMP, company policies, and other quality or regulatory requirements to ensure product quality. While under the supervision of a pharmacist, responsibilities include preparing compounded products, executing batch production records, documentation accuracy, equipment operation tasks, participating in environmental control activities, and supporting quality system requirements unique to 503B manufacturing. The ideal candidate will be Sterile Certified and have extensive experience in sterile and/or 503B compounding environments, with a commitment to delivering high-quality pharmaceuticals.

DUTIES AND RESPONSIBILITIES

• Perform sterile compounding aseptic technique in ISO 5 primary engineering control within ISO 7 cleanroom in compliance with cGMP requirements and company policies.
• Perform production operations within ISO 8 cleanroom including weighing, mixing, and processing APIs and excipients.
• Perform pre/post-production operations within controlled non-classified areas.
• Complete required training and qualification programs. Show proficiency in ongoing competency assessments.
• Maintain cleanroom compliance through routine cleaning and disinfecting procedures.
• Execute batch records to ensure accurate and consistent product preparation.
• Complete all logbooks and batch documentation following Good Documentation Practices.
• Prepare work areas, equipment, and ingredients ahead of production activities.
• Operate, clean, and maintain cleanroom environment and equipment.
• Perform visual inspection, labeling, and packaging of finished products.
• Assist with production demands and departmental tasks to meet schedule requirements.
• Participate in process improvement initiatives and root cause analysis to enhance productivity and quality.
• Support onboarding and training new team members.
• Adhere to all company policies, regulatory standards, and quality expectations.
• Perform additional duties as assigned.

SUPERVISORY RESPONSIBILITIES

N/A

QUALIFICATIONS

[PH3] :

• Sterile/IV Certified Pharmacy Technician (preferred).
• Two years of sterile compounding experience in 503B facility preferred.
• Strong understanding of cGMP regulations standards applicable to 503B compounding.
• Ability to read and understand production and technical documents as well as perform calculations.
• Open and flexible availability. Ability to work overtime and weekends as required.
• Comfortable working in full sterile gowning for extended periods.
• Able to use necessary equipment and technology devices.
• Proficient with MS Office application skills.
• Strong attention to detail, reliability, and commitment to compliance.
• Good interpersonal skills and communication skills.
• Able to work well with others in a team-oriented environment.
• Professional, outgoing, friendly, organized.
• Reliable, ready to learn, and trustworthy.
• Must have reliable transportation.
• Must be able to pass criminal background check and drug testing.
• High school diploma, general education degree (GED), or higher.

COMPETENCIES

Teamwork

• Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Quantity
• Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Attendance/Punctuality
• Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Dependability
• Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

Ability to stand for extended time (preferred 8 hours). Able to lift up to 30 lbs. Clean, well-groomed. Daily dress code will be scrubs. Manual dexterity to handle and manipulate small objects. Work in a well-lit and climate-controlled environment.

Pay:

$20.00

• $24.

00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Paid sick time Paid time off Prescription drug insurance Vision insurance

Experience:

Sterile Compounding :

2 years (Required)

License/Certification:

Sterile/IV Certified Pharmacy Technician (Required)

Work Location:

In person Sterile Operator 3745 Highway 6, Sugar Land, TX 77478 $20

• $24 an hour
• Full-time $20
• $24 an hour

•

Full-time SUMMARY:

The Sterile Operator plays a vital role in our team, responsible for cGMP-compliant production and aseptic processing of sterile products in controlled cleanroom environments within a 503B outsourcing facility. The position requires strict adherence to cGMP, company policies, and other quality or regulatory requirements to ensure product quality. While under the supervision of a pharmacist, responsibilities include preparing compounded products, executing batch production records, documentation accuracy, equipment operation tasks, participating in environmental control activities, and supporting quality system requirements unique to 503B manufacturing. The ideal candidate will be Sterile Certified and have extensive experience in sterile and/or 503B compounding environments, with a commitment to delivering high-quality pharmaceuticals.

DUTIES AND RESPONSIBILITIES

• Perform sterile compounding aseptic technique in ISO 5 primary engineering control within ISO 7 cleanroom in compliance with cGMP requirements and company policies.
• Perform production operations within ISO 8 cleanroom including weighing, mixing, and processing APIs and excipients.
• Perform pre/post-production operations within controlled non-classified areas.
• Complete required training and qualification programs. Show proficiency in ongoing competency assessments.
• Maintain cleanroom compliance through routine cleaning and disinfecting procedures.
• Execute batch records to ensure accurate and consistent product preparation.
• Complete all logbooks and batch documentation following Good Documentation Practices.
• Prepare work areas, equipment, and ingredients ahead of production activities.
• Operate, clean, and maintain cleanroom environment and equipment.
• Perform visual inspection, labeling, and packaging of finished products.
• Assist with production demands and departmental tasks to meet schedule requirements.
• Participate in process improvement initiatives and root cause analysis to enhance productivity and quality.
• Support onboarding and training new team members.
• Adhere to all company policies, regulatory standards, and quality expectations.
• Perform additional duties as assigned.

SUPERVISORY RESPONSIBILITIES

N/A

QUALIFICATIONS

[PH3] :

• Sterile/IV Certified Pharmacy Technician (preferred).
• Two years of sterile compounding experience in 503B facility preferred.
• Strong understanding of cGMP regulations standards applicable to 503B compounding.
• Ability to read and understand production and technical documents as well as perform calculations.
• Open and flexible availability. Ability to work overtime and weekends as required.
• Comfortable working in full sterile gowning for extended periods.
• Able to use necessary equipment and technology devices.
• Proficient with MS Office application skills.
• Strong attention to detail, reliability, and commitment to compliance.
• Good interpersonal skills and communication skills.
• Able to work well with others in a team-oriented environment.
• Professional, outgoing, friendly, organized.
• Reliable, ready to learn, and trustworthy.
• Must have reliable transportation.
• Must be able to pass criminal background check and drug testing.
• High school diploma, general education degree (GED), or higher.

COMPETENCIES

Teamwork

• Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Quantity
• Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Attendance/Punctuality
• Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Dependability
• Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

Ability to stand for extended time (preferred 8 hours). Able to lift up to 30 lbs. Clean, well-groomed. Daily dress code will be scrubs. Manual dexterity to handle and manipulate small objects. Work in a well-lit and climate-controlled environment.

Pay:

$20.00

• $24.

00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Paid sick time Paid time off Prescription drug insurance Vision insurance

Experience:

Sterile Compounding :

2 years (Required)

License/Certification:

Sterile/IV Certified Pharmacy Technician (Required)

Work Location:

In person