Pharmaceutical Operator

BioSpace; Charlottesville (VA); On-site; USD 34,000 - 41,000; Full time

Job summary

Afton Scientific in Virginia is seeking a non-exempt manufacturing operator to support the sterile line, batch records, and SOP compliance. The role involves operating production equipment and maintaining documentation for clinical to commercial manufacturing.

The position requires the ability to work in a clean room, lift up to 50 pounds, and function with minimal supervision in a team environment. Prior manufacturing experience is preferred for this non-sponsor role.

Qualifications

• Ability to read and write English.
• Physically able to stand and lift up to 50 pounds.
• Able to work near others in a production facility and in clean room.
• Must work with minimal supervision.

Responsibilities

• Perform manufacturing processes and operate equipment (washers, autoclave, dry heat oven, sealers, vial washer, ultrasonic cleaner).
• Follow Batch Records and SOPs for production operations.
• Maintain batch records and production logs; write and review master documents.
• Write Operation Deviation Reports and review production documentation.
• Supervise contract production employees as applicable.
• Maintain inventory in control warehouse space.
• Maintain cleanliness and order in the production area.
• Review and assemble production records for completeness.

Skills

Reading & writing English

Physical stamina

Team safety culture

Clean room readiness

Minimal supervision

Education

HS diploma or GED

Associates or Bachelor's preferred

Job description

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

• Serving clients in 18 Countries
• Successful NDA and ANDA drug registrations
• In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

Pay Details:

Non-exempt position, range of $25 - $30 per hour, depending on level of experience.

Essential Functions

• Perform manufacturing processes and operate production equipment, including, but not limited to: washers, autoclave, dry heat oven, heat sealers, vial washer, ultrasonic cleaner.
• Perform production operations according to Batch Records and Standard Operating Procedures (SOPs)
• Maintain proper documentation (batch records, production logs, etc.)
• Write and review master documents as applicable: SOPs and batch records
• Write Operation Deviation Reports
• Supervise contract production employees as applicable
• Maintain inventory of control warehouse space
• Perform production and maintenance activities in the Aseptic Processing Area (APA)
• Write and edit documents including: procedures, deviations, master batch records, protocols and reports as necessary
• Perform initial assembly and review of completed production records for completeness
• Maintain order and cleanliness in production area

Knowledge, Skills & Abilities

• Ability to read and write English. Dress, speak and act in a professional manner
• Physically able to stand for extended periods of time, mover objects up to 50 pounds, bend and reach to access equipment, have near vision correctable to 20/20 and be able to wear corrective eyewear to achieve this, if necessary.
• Must be capable of working in close proximity to other employees, regardless of gender, in the confined environment of the production facility.
• Must be capable of working in the clean room for uninterrupted extended periods
• Ability to maintain neat and accurate records required
• Must be able to work with minimal supervision.

Requirements For Education And Experience

• Minimum of high school diploma or GED; Associates or Bachelor’s degree desirable
• One year of manufacturing experience required. Three years manufacturing experience or more strongly preferred.
• Clean room experience preferred.