Summary
DPS has an exciting opportunity for a CQV Project Manager that will be responsible to deliver assigned CQV projects to support ECQ Top Tier Biopharma Client. The ECQ Department is responsible for equipment qualification, computer systems validation, and timely release of the equipment and systems to the end user.
The Scope Projects may include manufacturing and laboratory facility, utilities, common equipment (refrigerators, freezers, incubators, biosafety cabinets) and laboratory benchtop computer systems.
Key Responsibilities
? Strong pharmaceutical project management skills and proven experience in having managed CQVl projects with emphasis on Cell Therapy and/or Biologics clinical and/or commercial manufacturing and development laboratories in a cGMP environment.
? Understanding of GMP, regulatory, environmental, and OSHA regulations as it relates to Engineering, Facilities Operations and Construction.
? Understanding of financial management as it relates to capital and expense spending and project cash flow forecasting.
? Familiar with the use of the Stage Gate Process, RPM (Project Capital System), SAP and SRM (Purchase Order System) a plus.
? Pro-active in solving challenging project issues with the ability to develop creative solutions.
? Experience in total project delivery in a cGMP environment (from concept to validation and start-up process). Leads the development of the CQV project scope and objectives in support of the business strategy dealing with clients and stakeholders.
? Exhibits project leadership and effective decision making throughout each project. Leads and promotes effective teamwork by engaging ECQ, Facilities, and key clients and stakeholders.
? Possesses broad knowledge of the functional requirements of pharmaceutical facilities, utilities, equipment and CQV best practices, while ensuring that appropriate internal and external resources are incorporated into the project design and execution.
? Strong understanding of construction and qualification and validation terminology and CQV documents.
Skills & Qualifications
? EIT/PE License a plus.
?Pharmaceutical CQV projects, especially with Cell Therapy or Biologics Manufacturing Facilities & Labs.
? Leads the scheduling, planning, control and effective coordination of all the parallel activities related to each project and maintains project schedule through minimal unanticipated schedule challenges.
? Achieves high customer satisfaction by delivering finished projects that are fully commissioned, qualified and ready for GMP operation, meet all requirements of stakeholders and stay within a predetermined schedule.
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 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
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