CQV Manager

Summary:

DPS Group has an exciting opportunity for a BioPharma CQV Manager with proven CQV Validation leadership experience in complex BioPharma lab and manufacturing environments. This position will be within the cell and gene therapy space. The ideal candidate will effectively lead and manage CQV validation objectives, activities, and staff ensuring the highest level of quality, accuracy, and safety while staying on schedule and within determined budgets.

Key Responsibilities:

Responsibilities include, but are not limited to:

• Effectively interact with client/owner senior management constructively while maintaining CQV scope, resources, and staff.
• Authoring and/or oversee the writing of User Requirement Specifications, Design Qualifications, Commissioning Protocols, and executing testing protocols while utilizing several CQV methodologies and management principles.
• Track budgets, forecasting, planning, and reporting to the owner/client management.
• Successfully lay out and maintain a protocol generation schedule for the designated scope based on associated requirements of validation objectives
• Preparation and processing of turnover packaging and validation documentation in eDMS (electronic document management system).
• Strategize, collaborate, and support the resolution of engineering/validation issues found during lab or manufacturing equipment validation.
• Attend meetings as required to support assigned validation goals and objectives
• Coordinate with related project contractors and equipment vendors to execute required tests.
• Display thorough proficiency with reviewing required CQV documents following established standards and templates
• Support Validation Master Plan development

Skills & Qualifications:

• Bachelor of Science degree in Chemical Engineering or Mechanical Engineering or related major
• 10 years of CQV experience or equivalent combination of education and experience
• Experience working in a multi-disciplinary BioPharma team
• Any prior Cell or Gene Therapy Experience a plus
• Demonstrated CQV experience in design consultancy and/or client-site environments
• Knowledge of typical biotech/pharmaceutical manufacturing systems and equipment
• Excellent interpersonal and team leadership skills
• Excellent analytic, problem-solving, and decision-making skills
• Advanced time management and organizational skills
• Proficient in Microsoft Office, Project, Adobe
• Experience with Bluebeam, Automation and MES Systems a plus
• Previous Experience working in a cGMP and FDA regulated environment. (Clean rooms, BSL 1-4, ISO classified spaces)
• CQV PM will have experience leading and managing various CQV projects and teams. Possess a strong working knowledge of utilities and process systems and equipment
• Proven track record of consistently creating project timelines and reporting deliverables
• CSV experience a plus

Experience with the following types of documentation:

• Commissioning functional and pre-functional testing protocols/checklists
• Qualification protocols (DQ/IQ/OQ/PQ)
• User and Functional Requirements Specification (URS)
• Standard Operating Procedures and Work Instructions (SOPs and WIs)
• System Impact Assessment based on ISPE’s Baseline Guide.
• Specifications (URS/FRS/DDS/CS)
• FAT and SAT protocols
• Field observation forms
• Instrument Data Forms/Calibration forms
• Strong knowledge of GxP, ISPE and ASTM E2500.
• Data and turnover package compilation
• Deviation tracking and investigation including troubleshooting and retests
• Route documents through client review and approval process
• Knowledge of System Risk Assessments (SRA), Commissioning Test Plans (CTP), and Installation/Operational Verification (IOV)

The Company:

DPS Group is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.