IPS-Integrated Project Services
Job Description
At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a
CQV Project Leader
to join our team out of our office located in ____________.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will interface directly with IPS clients in project delivery and may also manage standalone commissioning services for non-FDA regulated clients.
Position Responsibilities
Assist an assigned Project Manager or be solely responsible for delivering compliance projects to IPS clients.
Provide timely feedback and reports to project managers or management regarding project status and issues.
Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
Support, train, and guide validation specialists/engineers in delivering C/Q/V services for assigned projects.
Prepare and manage C/Q/V documents following established standards, including:
C/Q/V Master Plans
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Manage field/site activities, including attending and witnessing FATs and SATs, executing commissioning forms, verifying drawings, and assisting in deviation investigations.
Coordinate with project delivery or construction management for start-up and testing.
Participate in proposal development, scope definition, bid meetings, and budgeting.
Perform C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Join a caring, nimble team delivering world-class designs for pharmaceutical clients and advancing your career!
Qualifications & Requirements
Bachelor of Science in Engineering required for Engineers; related field for Validation Specialists.
5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Experience in writing and executing PFC, FC, IQ, OQ, PQ forms and protocols for GMP utilities, equipment, systems, and software.
Experience with cleaning, processes, computer systems, methods, and validation activities is beneficial.
Understanding of GMP/Validation disciplines and pharmaceutical regulations.
Experience with risk-based approach to commissioning and qualification is beneficial.
Proficiency with Microsoft Office applications.
Knowledge of project management principles.
About Us
IPS, a Berkshire Hathaway company, is a global leader in biotech and pharmaceutical solutions. With over 3,500 professionals across 45 offices in 17 countries, we provide consultancy, engineering, project controls, construction management, and compliance services. Visit www.ipsdb.com for more information.
We are an equal opportunity employer and welcome all qualified applicants.
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At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a
CQV Project Leader
to join our team out of our office located in ____________.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will interface directly with IPS clients in project delivery and may also manage standalone commissioning services for non-FDA regulated clients.
Position Responsibilities
Assist an assigned Project Manager or be solely responsible for delivering compliance projects to IPS clients.
Provide timely feedback and reports to project managers or management regarding project status and issues.
Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
Support, train, and guide validation specialists/engineers in delivering C/Q/V services for assigned projects.
Prepare and manage C/Q/V documents following established standards, including:
C/Q/V Master Plans
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Manage field/site activities, including attending and witnessing FATs and SATs, executing commissioning forms, verifying drawings, and assisting in deviation investigations.
Coordinate with project delivery or construction management for start-up and testing.
Participate in proposal development, scope definition, bid meetings, and budgeting.
Perform C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Join a caring, nimble team delivering world-class designs for pharmaceutical clients and advancing your career!
Qualifications & Requirements
Bachelor of Science in Engineering required for Engineers; related field for Validation Specialists.
5+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Experience in writing and executing PFC, FC, IQ, OQ, PQ forms and protocols for GMP utilities, equipment, systems, and software.
Experience with cleaning, processes, computer systems, methods, and validation activities is beneficial.
Understanding of GMP/Validation disciplines and pharmaceutical regulations.
Experience with risk-based approach to commissioning and qualification is beneficial.
Proficiency with Microsoft Office applications.
Knowledge of project management principles.
About Us
IPS, a Berkshire Hathaway company, is a global leader in biotech and pharmaceutical solutions. With over 3,500 professionals across 45 offices in 17 countries, we provide consultancy, engineering, project controls, construction management, and compliance services. Visit www.ipsdb.com for more information.
We are an equal opportunity employer and welcome all qualified applicants.
#J-18808-Ljbffr