Validation Manager (Design Group)
About Us:
Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors.
Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries.
By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief:
to use the power of business to build a better world.
Job Description:
Job SummaryThe Validation Manager will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment.
ResponsibilitiesValidation Manager will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
The Validation Manager will help lead business development efforts in the region as it relates to engaging with new clients in the life sciences sector, and expanding our engagements with existing clientsThe Validation Manager will be responsible for developing project scope statements, estimates and proposals.
Will work on multiple projects simultaneouslyThis role will assist in the development of policies, programs and project master planning.
RequirementsMinimum of 7 years' experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
This position requires experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
Experience with financial systems, project and client administration andThis position requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.
Diverse experience in leading project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
Project Management experience in managing scope, cost, schedule, quality and risk is required.
Experience in team building, mentorship and multi-discipline collaborationDisplayed leadership in a consulting and service environment EducationBS Degree in Engineering or related technical degree.
Barry-Wehmiller is an equal opportunity employer.
M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company:
Design Group US Inc.
Estimated Salary: $20 to $28 per hour based on qualifications.
Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sectors.
Our nearly 1,500 technical and engineering experts have direct industry experience in industrial automation, control system integration, facility and process engineering, architecture, construction management, regulatory compliance, enterprise technology and other consulting services.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries.
By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief:
to use the power of business to build a better world.
Job Description:
Job SummaryThe Validation Manager will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility and process equipment.
ResponsibilitiesValidation Manager will interface with clients, lead teams of validation professionals, and provide subject matter expertise in the validation of a variety of utility, facility and process equipment.
The Validation Manager will help lead business development efforts in the region as it relates to engaging with new clients in the life sciences sector, and expanding our engagements with existing clientsThe Validation Manager will be responsible for developing project scope statements, estimates and proposals.
Will work on multiple projects simultaneouslyThis role will assist in the development of policies, programs and project master planning.
RequirementsMinimum of 7 years' experience with increasing responsibility in validation/quality service and project management of life sciences, biotech or other FDA regulated projects.
This position requires experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
Strong understanding of EPCMV, Quality by Design and risk-and science-based approaches for compliance are desired.
Experience with system and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis desired.
Experience with financial systems, project and client administration andThis position requires strong leadership, verbal communication, technical writing, project management tools and word processing skills.
Diverse experience in leading project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
Project Management experience in managing scope, cost, schedule, quality and risk is required.
Experience in team building, mentorship and multi-discipline collaborationDisplayed leadership in a consulting and service environment EducationBS Degree in Engineering or related technical degree.
Barry-Wehmiller is an equal opportunity employer.
M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.
Company:
Design Group US Inc.
Estimated Salary: $20 to $28 per hour based on qualifications.
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