Validation Specialist

Job Description

Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS' clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.

• Write C/Q/V documents following established standards and templates, including but not limited to the following:
  • Commissioning Forms
  • C/Q/V Protocols and Summary Reports
  • Standard Operating Procedures
  • Impact Assessments
  • Specifications (URS/FRS/DDS)
  • FATS/SATs
• Perform field/site activities including, but not limited to, the following:
  • Attend and witness FATs and SATs as a representative of IPS clients.
  • Execution of commissioning forms and witnessing of vendor start-up and testing.
  • Execution of C/Q/V protocols.
  • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
  • Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
  • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
  • Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
• Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services
• Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
• Other duties as assigned.

• Associates or bachelor's degree in related field preferred.
• Entry level position. 0 to 2 years of relevant experience.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA helpful.

• This position will have up to 100% travel to site, or as required by the assigned project.
• Position may be assigned to client site for an extended period of time.
• Overnight travel or staying in the city of Client's location is possible depending on assignment.
• Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan.
• Position will visit Client sites and will be required to adhere to stated safety rules.
• Position may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
• This position is a safety sensitive position.
• The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas.

• Proficiency with Microsoft Office applications (Word, Excel, Project, Power point, etc).
• Personal skills and traits include:
  • Sense of urgency
  • Team player
  • Able to multi-task
  • Effective time management
  • Able to effectively prioritize
  • Good interpersonal skills
  • Attention to detail
  • Excellent customer service skills
• Leads by example.
• Deems the respect of upper management, peers and subordinates.
• Empowers staff to succeed.
• Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
• Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion's technical advancement, which supports our corporate goals. Maintain professional conduct and deliver services in a professional and acceptable fashion.
• Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).

• Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization.
• Must strive for excellence in all aspects of job performance. Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do.
• Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system.
• Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other.
• Must act in an ethical, professional and…