Pharmaceutical Cleanroom Technician

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

This position will be responsible for cleaning of pharmaceutical manufacturing facility (ISO7/ISO8 cleanroom) and QC labs, supporting manufacturing activities of the Bioscience Laboratories-Campbell (BSL) site.    

Job Details

Cleaning:

Responsible for pharmaceutical manufacturing facility (ISO7/ISO8 cleanroom) and QC lab cleaning, sanitizing and associated decontamination.  Prepare all cleaning disinfectants/ reagents.  Perform decontamination autoclave runs for garments, BSL-3 waste and process waste as necessary.  Perform all facility waste removal, and ensure stocking of clean room gowning supplies, laboratory cleaning supplies.  Ensure proficiency in operating all cleaning equipment.  Ensure proper documentation for all cleaning activities, following SOP and regulatory requirements.

Manufacturing Support:

Responsible for supporting essential manufacturing activities, for example: run GMP glassware washer, and decontamination autoclave loads, decontaminate equipment and facility.

Inventory management of the items intended for BSL Manufacturing and MTS. Routine physical cycle counts and forecasting will be performed to ensure the availability of items required for the operation of the facility. Routinely working with all the internal departments to coordinate inventories is required on a daily basis.

Additionally, working with external vendors and supplier to provide and improve efficient on time deliveries.

Communicate information effectively through updates, reports, and summaries.

Regulated Responsibilities (including cGMP and EHS)

AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Position requires individual to work with Select Agents. Access to, and use of, select agents is covered by Federal policies. Violation of, or failing to support the intent of, Select Agent policies, regulations, or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications

 

Education

• BA / BS in a science or related discipline, with a minimum of 1 to 2 years’ experience in a GMP pharmaceutical or cleanroom environment.

• Or with high school diploma /GED, with a minimum of 3 to 5 years’ experience in a GMP pharmaceutical or cleanroom environment.

Experience: Technical

• Experience and working knowledge in cGMP cleanroom environment compliance and following SOPs is critical.

• Experience of preparing, and cleaning with corrosive disinfectants is required.

• Able to perform cleanroom gowning, and use of Powered Air Purifying Respirator (PAPR).

• Experience in running production equipment for example GMP glassware washer, autoclave is desired. 

Experience: IT Systems

• Strong user of Word, Excel, PowerPoint

• Familiar with other enterprise systems, for example, SAP and Workday system.

Experience: Regulatory

• Must be able to acquire security background clearance from US Department of Commerce, FBI and CDC.

 

 

 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.