Validation Engineer
Position Responsibilities
IPS is hiring! We are looking for talented Validation Engineers to join our industry leading Commissioning, Qualification and Validation (CQV) team based at a client located in Swiftwater, PA.
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.
Job Duties and Responsibilities
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.
Support development and validation activities
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.
Thorough knowledge of vial/syringe filling equipment to identify process for CPP's
Maintain professional conduct and deliver services in a professional and acceptable fashion.
Become self-sufficient and effectively work with limited supervision.
Make recommendations to IPS for possible project and procedural improvements.
Support and provide guidance for entry level staff and co-ops in the delivery of C/Q/V services.
Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
Special projects as assigned.
Qualifications & Requirements
Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case by case basis.
5 to 7 years in Process Validation (Formulation/Filling)
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.
Ability to use E Doc (templates, workflows, and approval)
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, 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
Company Overview
About Us
IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over twenty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 1,000 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.
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, affirmative action employer of protected veterans (M/F/D/V).
Attention Search Firms / Third Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
IPS is hiring! We are looking for talented Validation Engineers to join our industry leading Commissioning, Qualification and Validation (CQV) team based at a client located in Swiftwater, PA.
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.
Job Duties and Responsibilities
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.
Support development and validation activities
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.
Thorough knowledge of vial/syringe filling equipment to identify process for CPP's
Maintain professional conduct and deliver services in a professional and acceptable fashion.
Become self-sufficient and effectively work with limited supervision.
Make recommendations to IPS for possible project and procedural improvements.
Support and provide guidance for entry level staff and co-ops in the delivery of C/Q/V services.
Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
Special projects as assigned.
Qualifications & Requirements
Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case by case basis.
5 to 7 years in Process Validation (Formulation/Filling)
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.
Ability to use E Doc (templates, workflows, and approval)
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, 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
Company Overview
About Us
IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over twenty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 1,000 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.
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, affirmative action employer of protected veterans (M/F/D/V).
Attention Search Firms / Third Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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