Sr. Engineer - Commissioning & Qualification

Company Info
Azzur
Willow Grove, PA, United States

Phone: 2678809416
Web Site: www.azzur.com

Company Profile
col-narrow   

Title:

Sr. Engineer - Commissioning & Qualification

Location:

Waltham, MA 

Job ID:

34361
col-wide   

Job Description:

We are seeking a talented Commissioning and Qualification (C&Q) Engineer to provide technical and project support for client projects. Responsible for IQ/OQ and PQ deliverables as necessary in the design, installation, commissioning and qualification of equipment, systems, and processes according to established quality and regulatory standards. Duties include:

- Analyze and resolve issues and provide guidance in the delivery of Qualification/Validation services

-Perform all aspects of cleaning validation and risk assessments

- Develop/review technical documentation and reports pertaining to systems and processes including: Impact/Critical Aspect Assessment; Commissioning Forms/Test Packs; Risk Assessment;Quality SOPs,Validation Master Plans, IQ/OP/PQ Protocols

Qualifications

  • College degree and three  plus years of C&Q experience with equipment and systems used in pharmaceutical manufacturing.
  • Experience in writing/execution of Equipment and Software protocols
  • Knowledge and understanding of regulatory requirements of GMP/FDA
  • Proficiency with diverse equipment/system operations (e.g. SIP,CTU,Chromatography, Mixers, Autoclaves, etc)
  • Good organization, communication, and interpersonal skills
  • Ability to effectively work with clients and staff in fast-paced project team environment

Great opportunity to join growing and well-regarded consulting leader offering attractive work environment, career growth and generous benefits! 

Azzur Core Values: Put Others First, Courage to Take Action, Take Personal Responsibility, Integrity - Do the Right Thing and Have Fun!