IPS - Integrated Project Services, LLC
CQV, Consultant-SS
IPS - Integrated Project Services, LLC, Trenton, New Jersey, United States,
Job DescriptionPerforms 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. Performs site auditing, quality reviews, and C/Q/V services as required to meet project requirements.KEY ACTIVITIES AND RESPONSIBILITIESDemonstrated / recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device, etc.), by equipment/systems (critical utilities, manufacturing equipment, packaging equipment, etc.), or by validation activity (commissioning and qualification, process, cleaning, CSV, methods, etc.). Provide working knowledge in the delivery of technical projects in these areas.Provide consulting-based services in areas of expertise.Support, train, and provide guidance to validation specialists/engineers in the delivery of C/Q/V services and areas of expertise.Perform cGMP audits of clients' facilities and quality systems.Write or provide input to C/Q/V documents following established standards and templates, including but not limited to the following:
C/Q/V Master PlansCommissioning FormsC/Q/V Protocols and Summary ReportsStandard Operating ProceduresRisk AssessmentsSpecifications (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 non-conformance and out of specification investigation and resolution of problems and issues encountered during field execution activities.Audit project deliverables to assure compliance with established standards. Review work of assigned project team.Be self-sufficient and effectively work with limited supervision.Read, understand, and utilize IPS Best Practices and SOPs for delivery of client services.Perform work to meet IPS budget requirements, meet personal billability goals, and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management of project status and issues.Assist the project leader and/or project manager with project management activities, (schedules, attend/lead meetings, maintenance of budgets/deliverables, etc.). Assume PL/PM responsibilities as requested and required to meet project requirements.Act as an IPS representative for developing new company-wide business opportunities and continue to support repeat business.Develop client relationships and act as IPS liaison (point of contact) on project/client sites.Maintain professional conduct and deliver services in a professional and acceptable fashion.Assist in recruiting new staff members and promoting IPS to potential hires.Make recommendations to IPS for possible project and procedural improvements.Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies. Present at industry/trade organization seminars.Other duties as assigned.Qualifications & RequirementsREQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCEBachelor's degree in Engineering or a related discipline or an equivalent technical degree.A minimum of 10 years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of Master Plans, PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes.General exposure and experience in the discipline of GMP/Validation 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, and international Standards and guidance (ASTM, ICH, ISPE, etc.).Experience with Risk-Based Approach to Commissioning and Qualification.CONTEXT AND ENVIRONMENT AND SAFETYThis position will have up to 100% travel, 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.DEMONSTRATED COMPETENCIESProficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc).Personal skills and traits include:
Sense of urgencyTeam playerAble to multi-taskEffective time managementAble to effectively prioritizeGood interpersonal skillsAttention to detailExcellent 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 champions technical advancement, which supports our corporate goals.Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).Core Value Candidate QualificationsMust 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 display creativity and innovation by continually working to improve solutions, tools, methods, and service delivery systems.Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other. Must act in an ethical, professional, and respectful manner at all times.Must exhibit the ability to build and sustain long-term relationships of mutual value through teamwork.Must be driven to succeed and committed to goal attainment.About UsIPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.SpecialtiesProcess 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.All qualified applicants will receive consideration for employment at IPS 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. IPS is proud to be an affirmative action and equal opportunity employer.
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C/Q/V Master PlansCommissioning FormsC/Q/V Protocols and Summary ReportsStandard Operating ProceduresRisk AssessmentsSpecifications (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 non-conformance and out of specification investigation and resolution of problems and issues encountered during field execution activities.Audit project deliverables to assure compliance with established standards. Review work of assigned project team.Be self-sufficient and effectively work with limited supervision.Read, understand, and utilize IPS Best Practices and SOPs for delivery of client services.Perform work to meet IPS budget requirements, meet personal billability goals, and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management of project status and issues.Assist the project leader and/or project manager with project management activities, (schedules, attend/lead meetings, maintenance of budgets/deliverables, etc.). Assume PL/PM responsibilities as requested and required to meet project requirements.Act as an IPS representative for developing new company-wide business opportunities and continue to support repeat business.Develop client relationships and act as IPS liaison (point of contact) on project/client sites.Maintain professional conduct and deliver services in a professional and acceptable fashion.Assist in recruiting new staff members and promoting IPS to potential hires.Make recommendations to IPS for possible project and procedural improvements.Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies. Present at industry/trade organization seminars.Other duties as assigned.Qualifications & RequirementsREQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCEBachelor's degree in Engineering or a related discipline or an equivalent technical degree.A minimum of 10 years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of Master Plans, PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes.General exposure and experience in the discipline of GMP/Validation 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, and international Standards and guidance (ASTM, ICH, ISPE, etc.).Experience with Risk-Based Approach to Commissioning and Qualification.CONTEXT AND ENVIRONMENT AND SAFETYThis position will have up to 100% travel, 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.DEMONSTRATED COMPETENCIESProficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc).Personal skills and traits include:
Sense of urgencyTeam playerAble to multi-taskEffective time managementAble to effectively prioritizeGood interpersonal skillsAttention to detailExcellent 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 champions technical advancement, which supports our corporate goals.Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).Core Value Candidate QualificationsMust 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 display creativity and innovation by continually working to improve solutions, tools, methods, and service delivery systems.Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other. Must act in an ethical, professional, and respectful manner at all times.Must exhibit the ability to build and sustain long-term relationships of mutual value through teamwork.Must be driven to succeed and committed to goal attainment.About UsIPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.SpecialtiesProcess 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.All qualified applicants will receive consideration for employment at IPS 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. IPS is proud to be an affirmative action and equal opportunity employer.
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