Environmental Monitoring and Utilities Monitoring Technical Support, Quality Control Microbiology (Contract)

EM/UM Technical Support, Quality Control Microbiology

General Summary:

The Environmental Monitoring and Utilities Monitoring Technical support role will provide technical support for EM/UM team as a Subject Matter Expert (SME). This role will serve as a key resource within the organization, providing technical expertise in the areas of EM/UM sampling, testing, aseptic processing, and contamination control in accordance with regulatory standards.  This role reports to the Associate Director of Quality Control in Cell and Genetic Therapies (VCGT).

on site role. 

12 month contract with the chance to extend. 
 

Key Duties and Responsibilities:

• Demonstrates a strong understanding of sampling and microbiological testing methodologies including but not limited to EM, UM, Bioburden, Endotoxins, Sterility, Gram Stain, and Identification program per relevant regulatory standards
• Hands-on experience in the handling of microbiology lab instruments i.e. Vitek, Endosafe, BacT, MALDI-TOF, Isolator
• Organize, plan, and support team members with technical questions and problem-solving to ensure group efficiency and accountability
• Ensure compliance with current Good Manufacturing Practices (cGMP), as well as Health, Safety, and Environmental policies per Vertex standards
• Provide subject matter expertise in Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations
• Manages deviations and Corrective and Preventative Action (CAPA) implementation associated with Microbiological methodologies
• Support laboratory inspections and audits, including addressing follow-up actions and ensuring continuous improvement
• Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory CMC, and Analytical Development, to ensure alignment and effective communication between teams
• Provide guidance in drafting EM/UM Trend Reports 
• Assist with document revisions.

Knowledge and Skills:

• Extensive knowledge and experience of Quality Control methods and compendial requirements including but not limited to (Sterility, Endotoxin, Environmental monitoring, ID, APS/PAQ processes)
• Strong understanding of Aseptic processing and contamination control strategies in manufacturing facilities
• Extensive experience working in a GMP environment
• Strong communication and scientific writing
• Strong project management skills
• Experience with electronic systems such as LIMS and Quality Management Systems (Veeva) preferred

Education and Experience:

• Bachelor’s degree in Microbiology or related field.
• A minimum of 7 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization.

$60-$70/HR

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors