Aseptic Cleaning Technician Job at PCI Pharma Services (San Diego)

Job Description

The Aseptic Cleaning Technician must formulate cleaning solutions and sanitize manufacturing core, operation equipment, and monitor production processes and operations as necessary. The Technician will record information in documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), and review documentation as appropriate. This role frequently works in a professional manufacturing environment with computer equipment, machinery, tools, and loud noise and activity.

Job Responsibility

Perform sanitization duties in the cleanroom while aseptically gowned
Properly formulate sterile/nonsterile disinfectant cleaning solutions in Drug Product areas
Record and complete documentation as needed, including forms and logbooks in compliance with cGMP guidelines
Participates in regularly scheduled group trainings and departmental meetings
Internal investigations (Deviations, Safety Audits, Internal Audits)
Maintain facility and equipment through routine cleaning and sanitization in designated areas within the cleanroom as indicated in standard operating procedures
Operate general production equipment such as autoclaves
Formulate cleaning solutions and sanitize sterile/nonsterile Drug Product areas
Collect all used disinfectant solution waste and place in the appropriate disposal unit
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture

Requirements

High School Diploma or GED preferred
0-1 year of aseptic gowning, cleanroom, and/or cGMP experience
Ability to learn proper cleanroom behavior and aseptic technique concepts
Able to learn use of equipment documentation as required, including logbooks and binders
Ability to work independently or as team player
Detail Oriented
Ability to receive Aseptic Gowning Qualification will be required

Nice to have

Basic understanding of solution chemistry needed to properly mix chemicals is preferred
Comprehension of QAD, ACE, LIMS, and RAM is preferred
Familiarity with basic Microsoft Office programs such as Word, Excel, and Outlook is preferred

What we offer

paid time off
health insurance coverage (including dental and vision)
a flexible spending account
a 401(k) plan
eligibility for an annual performance bonus

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