Quality Assurance Validation Specialist

2 weeks ago

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

Position Overview:

IPS is a prominent entity in the field of innovative solutions tailored for the consulting, architecture, engineering, project management, procurement, construction oversight, and commissioning, qualification, and validation (CQV) of sophisticated facilities, particularly within the life sciences sector.

We are seeking a committed Validation Engineer to contribute to our esteemed team. In this capacity, you will engage in compliance-driven services that encompass commissioning, qualification, validation, and consulting, as outlined in project agreements with our clients. Adherence to IPS and client standards, as well as industry best practices and regulatory mandates, will be paramount. Additionally, you may provide independent commissioning services for clients not regulated by the FDA.

Key Responsibilities:

  • Develop C/Q/V documentation in accordance with established standards and templates, including but not limited to:
    • Commissioning Forms
    • C/Q/V Protocols and Summary Reports
    • Standard Operating Procedures
    • Impact Assessments
    • Specifications (URS/FRS/DDS)
    • FATs/SATs
  • Conduct field/site activities, which may include:
    • Attending and witnessing FATs and SATs on behalf of clients.
    • Executing commissioning forms and observing vendor start-up and testing.
    • Implementing C/Q/V protocols.
    • Verifying system drawings (P&IDs, as-builts, etc.).
    • Compiling data and generating reports for completed C/Q/V activities.
    • Assisting in the investigation of deviations and resolving issues encountered during field operations.
    • Collaborating with the Project Delivery department or Construction Management for start-up and vendor testing.
  • Primary duties involve C/Q/V of equipment and systems, including Computer System Validation (CSV) and automation, supporting the pharmaceutical, biotech, and medical device sectors.
  • Understand and apply IPS Best Practices and SOPs for compliance service delivery.
  • Ensure work aligns with IPS budgetary constraints and quality standards, providing timely feedback and reports to project leaders and management as needed.
  • Other responsibilities as assigned.

Qualifications & Requirements:

  • Bachelor's degree in Engineering.
  • Entry-level position - 0 to 2 years of relevant experience.
  • Familiarity with Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or Quality Assurance is advantageous. Experience in drafting and executing PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software is a plus.
  • General exposure to GMP/Validation disciplines with an understanding of pharmaceutical Design/Build/Commission/Validation processes and their relation to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA is beneficial.

Context & Safety:

  • This role may require extensive travel to project sites.
  • Assignments may involve extended periods at client locations.
  • Overnight travel may be necessary based on project needs.
  • Compliance with safety protocols at client sites is mandatory.
  • This position is safety-sensitive and involves fieldwork in various operational environments.

Preferred Competencies:

  • Proficiency in Microsoft Office Suite (Word, Excel, Project, PowerPoint, etc.).
  • Personal attributes include:
    • Sense of urgency
    • Team-oriented
    • Able to manage multiple tasks
    • Effective time management
    • Strong prioritization skills
    • Good interpersonal abilities
    • Attention to detail
    • Excellent customer service orientation
  • Demonstrates leadership and earns respect from colleagues and management.
  • Encourages staff development and technical training to enhance competency.
  • Promotes a collaborative and efficient work environment that recognizes achievement and teamwork.
  • Maintains professionalism in service delivery.
  • Collaborates with management to attract new talent and promote IPS.

Core Values:

  • Exhibits an entrepreneurial mindset by seeking opportunities to enhance organizational value.
  • Approaches work with enthusiasm and a positive attitude.
  • Demonstrates creativity and innovation in improving solutions and service delivery.
  • Commits to ethical and respectful conduct at all times.
  • Builds and sustains long-term, mutually beneficial relationships through teamwork.
  • Driven to achieve goals and committed to success.

About IPS:
IPS, a Berkshire Hathaway Company, stands as a global leader in delivering innovative business solutions for the biotechnology and pharmaceutical sectors. Through our operational expertise and industry-leading knowledge, we provide consultancy services, architecture, engineering, project management, construction oversight, and compliance services that empower clients to develop and manufacture life-impacting products.

IPS is proud to be an equal opportunity employer, welcoming all qualified applicants without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law.

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