Validation Specialist

Description

• Position will visit Client sites and will be required to adhere to stated safety rules.
• 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.
• Write C/Q/V documents following established standards and templates, including but not limited to the following:
• Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
• Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services
• Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
• 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.
• 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.
• Attend and witness FATs and SATs as a representative of IPS clients.
• Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).
• Execution of C/Q/V protocols.
• Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
• 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.
• Execution of commissioning forms and witnessing of vendor start-up and testing.
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
• Perform field/site activities including, but not limited to, the following:
• Position may visit active construction sites and will be required to take site safety training and adhere to site safety rules.

Requirements

• Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork.
• Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system.
• Excellent customer service skills
• 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.
• Able to multi-task
• This position will have up to 100% travel to site, or as required by the assigned project.
• Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc).
• 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.
• C/Q/V Protocols and Summary Reports
• Sense of urgency
• Effective time management
• Entry level position. 0 to 2 years of relevant experience.
• Attention to detail
• Associates or bachelor’s degree in related field preferred.
• Specifications (URS/FRS/DDS)
• Overnight travel or staying in the city of Client’s location is possible depending on assignment.
• Good interpersonal skills
• Able to effectively prioritize

Benefits

• Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan.

Training + Development

Interview process

Visa Sponsorship

Security clearance