Environmental Monitoring Technician

RESPONSIBILITIES

• Performs routine and non-routine environmental monitoring (EM) of Excellos Lab’s cGMP manufacturing facilities for total non-viable particulates, air viable particulates, and surface viable particulates per applicable standard operating procedures (SOPs).
• Safely operate and maintain all EM testing and laboratory equipment including validation, routine calibration, and preventive maintenance in accordance to established practices, SOPs, and test methodologies.
• Perform in-house enumeration including placing plates on test and movement between temperatures per assigned schedule.
• Coordinates shipment of collected samples to external laboratories.
• Responsible for timely completion of associated EM result summaries.
• Escalate any alert or action results to QC management.
• Assists and initiates the investigation and review of EM related quality events, including but not limited to EM excursions, deviations, non-conformances, and audit findings.
• Performs sampling for the gowning qualification program for all Excellos personnel.
• Reviews cleanroom EM data and assists in trending data and preparation of quarterly and yearly reports.
• Assists in development and revision of policies, standard operating procedures (SOPs) and other documents.
• Exhibits professional behavior with both internal and external customers.
• Interacts closely with Excellos departments and external partners to ensure efficient, compliant, and timely execution of project activities.
• Understands and adheres to the policies and standards as developed as part of the Excello Lab Quality.
• Participates as a team member and is accountable for own work responsibilities.
• Participates in departmental meetings and attend other meetings as assigned.
• Maintain inventory levels of raw materials, components, and supplies as required to support EM of the Cleanroom/production.
• Coordinates and manages all cleaning supplies and gowning re-stocking points with supply chain to support CT Cleanrooms.
• Performs other related duties as assigned or requested.

WORKING ENVIRONMENT

• Normal office environment.
• Cleanroom environment requires gowning in the form of scrubs, cleanroom gowns, hoods, gloves, sleeves, boot covers, and face masks.
• May be required to work a flexible shift structure to meet needs of the department.
• No makeup or jewelry can be worn when working in a cleanroom environment.

PHYSICAL REQUIREMENTS

• Must be able to stand in a cleanroom for prolonged periods of time
• Must be able to successfully gown to ISO7 standards for Cell Therapy (gowning in the form of scrubs, cleanroom gowns, hoods, gloves, sleeves, boot covers, and face masks)
• May be subject to prolonged sitting, reaching horizontally.
• Must be able to work on a computer 4 - 8 hours a day.
• Must have ability to move around office
• Must have ability to lift up to 30 pounds.

EQUIPMENT USED

• Standard office equipment such as computers, telephones, copy machines, fax machines and scanners.
• EM and laboratory equipment.

QUALIFICATIONS

Education:

• Associate Degree, or a combination of work experience and college coursework in the sciences required.

Experience:

• Minimum of two years of relevant experience in a pharmaceutical, biotechnology, or cell therapy manufacturing facility preferred.
• Experience with laboratory and aseptic manufacturing techniques.
• Cleanroom and GMP experience.

Skills:

• Good organizational and time management skills; must be able to establish priorities and self-organize tasks.
• Ability to perform accurate detail-oriented work.
• Must possess good verbal and written communication skills.
• Ability to trend and analyze data.
• Ability to perform tasks per cGMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices.
• Proven ability to meet deadlines, including time-sensitive tasks.
• Ability to use effective problem-solving techniques and make sound decisions.
• Ability to maintain confidentiality.
• Ability to work well with others.
• Ability to perform environment monitoring testing in a highly accurate and reproducible manner.
• Strong working knowledge of Microsoft Suite applications, including Word, PowerPoint and Excel.

This position is on site in San Diego, CA.

Shift: Monday - Friday 8:00am - 5pm

Salary range: Range $24 - $28 per hour