Quality Assurance Validation Specialist

2 weeks ago

Boulder, Colorado, United States IPS-Integrated Project Services, LLC Full time

Position Overview:

IPS, a leader in innovative solutions for the life sciences sector, is seeking a dedicated Validation Engineer to contribute to our esteemed team. This role involves delivering compliance services focused on cGMP standards, including commissioning, qualification, and validation, as outlined in project agreements.

Key Responsibilities:

  • Develop C/Q/V documentation adhering to established protocols, including:
    • Commissioning Forms
    • C/Q/V Protocols and Summary Reports
    • Standard Operating Procedures
    • Impact Assessments
    • Specifications (URS/FRS/DDS)
    • FATs/SATs
  • Conduct field activities such as:
    • Participating in FATs and SATs on behalf of clients.
    • Executing commissioning forms and overseeing vendor testing.
    • Implementing C/Q/V protocols.
    • Verifying system drawings and documentation.
    • Compiling data and generating reports for completed C/Q/V tasks.
    • Assisting in the investigation of deviations and resolving field execution challenges.
    • Collaborating with project teams for vendor testing and troubleshooting.
  • Focus on C/Q/V of equipment and systems, including CSV and automation, in support of pharmaceutical, biotech, and medical device sectors.
  • Adhere to IPS Best Practices and SOPs for compliance service delivery.
  • Ensure project work aligns with IPS budgetary and quality standards, providing timely updates to project leaders.
  • Perform additional duties as required.

Qualifications:

  • Bachelor's degree in Engineering.
  • Entry-level position with 0 to 2 years of relevant experience.
  • Familiarity with Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA is advantageous.
  • Basic understanding of GMP/Validation disciplines and regulatory requirements.

Work Environment:

  • This role may require extensive travel to project sites.
  • Prolonged assignments at client locations may be necessary.
  • Compliance with safety protocols is mandatory, especially in active construction settings.

Preferred Skills:

  • Proficiency in Microsoft Office Suite.
  • Strong personal attributes such as:
    • Sense of urgency
    • Team collaboration
    • Effective multitasking
    • Time management skills
    • Attention to detail
    • Excellent customer service
  • Ability to lead by example and foster a positive work environment.
  • Commitment to professional development and team success.

Core Values:

  • Demonstrate an entrepreneurial mindset by seeking opportunities to enhance organizational value.
  • Exhibit enthusiasm and a passion for the work.
  • Innovate continuously to improve processes and service delivery.
  • Maintain ethical and respectful conduct in all interactions.
  • Build and sustain valuable relationships through teamwork.

About IPS:
IPS is a global leader in providing innovative business solutions for the biotechnology and pharmaceutical industries. With a commitment to operational excellence and industry expertise, IPS delivers consultancy, engineering, project management, and compliance services that empower clients to create life-changing products.

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