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Commissioning, Qualification, and Validation (CQV) Manager

The Opportunity

Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in over 20 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1300 employees worldwide

Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.

The Scope

The CQV Manager will report to the CEO/ Plant Manager.

Responsibilities

  1. Overall accountability for company validation program including: commissioning & qualification, computerized system validation, thermal validation, decontamination & sterilization validation, process validation, cleaning validation, transport qualification, aseptic process simulation and validation maintenance activities.
  2. Performs strategic planning and development of activities for company CQV function, including compliance, capacity, timelines and directions. Collaborates closely with senior leadership team in meeting corporate and organizational goals through establishing and reporting of department or organizational metrics.
  3. Performs and ensures validation of GMP facilities through management of validation projects of various sizes while providing technical assistance. Acts as subject matter expert and resource to peers and colleagues.
  4. Establish, generate, and maintain CQV department procedures in compliance with company and industry standards.
  5. Owns and maintain the validation program quality systems.
  6. Develops Validation Plans for validation projects and oversee contract staff, when necessary, through development of statement of work and vendor selection.
  7. Write, review and approve associated commissioning, qualification and validation protocols and reports including executed protocols. Ensures appropriate resolution of protocol exceptions.
  8. Generate, review and approve CQV associated deviations, CAPAs. Perform/ lead investigations and RCAs as required.
  9. Perform CQV associated change control assessments.
  10. Primary point of contact for CQV associated audit requests. Present and defend validation studies during regulatory, partner and internal inspections.
  11. Authors or reviews validation section of annual periodic product reviews.
  12. Lead or participate in risk assessments and gap analysis.
  13. Lead continuous improvement initiatives.
  14. Develop work plans, assign tasks, and lead team(s).

Authority

  1. Authority for the CQV program and associated cGMP implementation and improvements.
  2. Authority to approve changes made to the CQV program.

Requirements

  • Degree in Biotechnology/ Chemical Engineering/ Bioengineering/ Life Sciences or related studies.
  • Minimum of 8 years in an engineering or quality role in a cGMP related role with at least 2 years in a people management role.
  • Highly adaptable and capable of performing in a dynamic working environment.
  • Knowledgeable on cGMP manufacturing of investigational products and their associated requirements. Able to ensure validation activities for the manufacturing of products in preclinical and clinical trials (Phase 1, 2, 3) are performed in a manner appropriate to the current stage of the product lifecycle.
  • Good grasp of aseptic processing knowledge pertaining to cGMP manufacturing of Cell & Gene Therapy associated products.
  • Strong understanding of regulations related to manufacturing of Cell & Gene Therapy products. Good ability to define validation deliverables suited for each product to fulfil regulatory requirements.
  • Knowledge of Validation Lifecycle Approach.
  • Familiarity and Understanding of Validation using risk-based approaches.
  • Experience in facility design, qualification and start up.
  • Ability to read/interpret engineering drawings and design documents.
  • Good understanding of computerized system validation and data integrity principles.
  • Strong technical writing abilities in being able to write from ground up SOPs and able to review as relevant to relevant ISPE/PDA, cGMP Guidelines and technical working documents.
  • Self-starter, self-motivated and task oriented. Able to motivate team to ensure deliverables are completed in a timely fashion.
  • Builds relationship and connects with colleagues in a way that creates a sense of team purpose and achievement.

Preferred Experience(s)

  • Strong interpersonal, organization and technical skills. Capability to work both independently and in a team environment with ability to provide guidance.
  • User experience with software tools on CMMS, QMS, EMS, LIMS.
  • Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel, Project, Visio).
  • Excellent written and verbal communications skills.
  • Strong understanding of global regulations (US, EU, MHRA, JP, Canada, Australia).
  • Experience with cleanroom, facility and validation of advanced processing equipment including bioreactors, fermenters, isolators, filling lines, freeze dryers, autoclaves, AHU and utilities.
  • Familiar with sterilization, bio-decontamination and material compatibility.
  • Superior communication, strategic, interpersonal, and negotiating skills. Able to provide advice as overall validation subject matter expert and openly communicate any relevant issues.
  • Prior experience working in a startup environment is ideal.

Apply now by submitting a Cover Letter and CV to [email protected].

For other job openings in Esco Lifesciences Group within the respective geographies, kindly refer to corporate website.