Aseptic Cleaning Technician - Part Time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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. 
 

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.

• 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. Group 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.

Shift:

Monday - Thursday 10:00PM - 2:00AM * Eligible for 10% pay differential

Sunday: 1:00pm - 5:00pm 

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• 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.

• 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. 

• Ability to work independently or as team player.

• Detail Oriented.

• Ability to receive Aseptic Gowning Qualification will be required.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• occasionally required to sit, and to reach to use computers and other office equipment

• occasionally stand for extended periods of time, up to four (4)