Current jobs related to CQV Specialist - Blue Bell, Pennsylvania - IPS-Integrated Project Services, LLC

Job Overview:

This application is intended for potential roles within our Commissioning, Qualification, and Validation (C/Q/V) department. Below are the responsibilities you may undertake if selected.

Engage in cGMP compliance-driven activities (including commissioning, qualification, validation, and consulting) as outlined in agreements with IPS clients. Adhere to IPS and client standards, industry best practices for C/Q/V services, and regulatory guidelines. You may also provide independent commissioning services for clients not regulated by the FDA.

Key Responsibilities:

• Draft C/Q/V documentation in accordance with established protocols and templates, which may include:
  • Commissioning Forms
  • C/Q/V Protocols and Summary Reports
  • Standard Operating Procedures
  • Impact Assessments
  • Specifications (URS/FRS/DDS)
  • FATs/SATs
• Conduct field/site operations, which may involve:
  • Participating in and observing FATs and SATs on behalf of IPS clients.
  • Completing commissioning forms and overseeing vendor start-up and testing.
  • Executing C/Q/V protocols.
  • Reviewing and validating system drawings (P&IDs, as-builts, etc.).
  • Gathering data and preparing reports for finalized C/Q/V activities, including ETOPs and protocol data packages.
  • Assisting in the investigation of deviations and resolving issues encountered during field activities.
  • Collaborating with the Project Delivery department or Construction Management for start-up and vendor testing.
  • Providing troubleshooting support as necessary.
• Focus on C/Q/V of equipment and systems, including Computer System Validation (CSV) and automation, in support of the pharmaceutical, biotech, and medical device sectors.
• Understand and apply IPS Best Practices and SOPs in delivering compliance services.
• Ensure work aligns with IPS budgetary and quality standards, providing consistent and timely updates to project leaders and management regarding project status and challenges.
• Other responsibilities as assigned.

Qualifications & Requirements:

• Associate or Bachelor’s degree in a relevant field is preferred.
• A minimum of 2 years of pertinent experience.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or Quality Assurance. Familiarity with writing and executing PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software is advantageous.
• General knowledge and experience in a GMP/Validation discipline, with an understanding of pharmaceutical Design/Build/Commission/Validate processes and their relation to regulatory requirements and cGMP regulations in the E.U. and U.S. FDA is beneficial.

Context & Safety:

• This role may require up to 100% travel, depending on project assignments.
• Assignments may involve extended periods at client sites.
• Overnight travel may be necessary based on project requirements.
• Compliance with IPS Travel Policy and any client-specific travel policies is required.
• Visits to client sites will necessitate adherence to established safety protocols.
• There may be visits to active construction sites, requiring completion of site safety training and compliance with safety regulations.
• This position is classified as safety-sensitive.
• The employee will engage in fieldwork at client sites within construction, process, packaging, manufacturing, research, or other operational areas.

Essential Competencies:

• Proficient in Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
• Key personal attributes include:
  • A sense of urgency
  • Team-oriented
  • Able to manage multiple tasks
  • Effective time management skills
  • Strong prioritization abilities
  • Good interpersonal communication
  • Attention to detail
  • Excellent customer service orientation
• Demonstrates leadership by example.
• Earns respect from management, peers, and subordinates.
• Encourages team success.
• Supports and implements technical training programs to ensure competency and advancement in alignment with corporate objectives.
• Fosters a collaborative and efficient work environment that recognizes achievement and promotes teamwork and technical growth.
• Maintains professionalism and delivers services in a respectful manner.
• Collaborates with department management in recruiting new talent and promoting IPS to prospective hires.

About IPS:
IPS, a Berkshire Hathaway Company, is a global leader in providing innovative solutions for the biotechnology and pharmaceutical sectors. With extensive operational expertise and industry-leading knowledge, IPS offers consultancy services, architecture, engineering, project controls, construction management, and compliance services that empower clients to develop and manufacture life-impacting products. Our recent acquisition, Linesight, enhances our capabilities in cost, schedule, risk, program, and project management across various sectors, including data centers, life sciences, and high-tech industries. With over 3,000 professionals in more than 45 offices across 17 countries, IPS is committed to excellence in service delivery.

Specialties:
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.

IPS is an equal opportunity employer and welcomes 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.