MAIN PURPOSE OF THE POSITION:
Provide supervision and performance management to a small team of Project Engineers. Provide project management for Facilities related projects at the HQ facility in San Diego and AMR region. Provide direct support and overall guidance for all Facilities related validation activities conducted within Manufacturing and related operations. Ensure validation activities align with the Quality department SVMP’s (Site Validation Master Plans).
Day to day management duties supporting the team of Project Engineers.
Prioritize tasks, projects and align resources to meet the demands of the business in respect of CAPEX projects and validation activities. Manage workflow through i2i project management system.
Lead the implementation and execution of projects from completion of planning to handover.
Define project tasks, resource requirements and develop full scale project plans.
Manage project budget and project resource allocation.
Constantly monitor and report on progress of the projects to all stakeholders.
Present reports defining project progress, problems and solutions.
Implement and manage project changes and interventions to achieve project outputs.
Develop, implement and deploy validation policies, procedures, and plans. Work alongside Technical functions and Manufacturing to create and execute validation plans, and equipment, systems and process validation studies.
Ensure all equipment, system and process validation studies meet regulatory compliance and internal company requirements.
Deploy and optimize successful validation processes for manufacturing facilities and equipment, computer systems, manufacturing processes, and cleaning processes. Ensure these processes are fully integrated with the overall Quality System.
Review and approve validation and engineering documents, change control, CAPA, and other supporting documentation.
Act as a key point of contact with the quality organization for the Validation Program. Provide guidance on requirements to ensure plant operations are maintained in a validated state.
Provide validation expertise and leadership including: coordinating and achieving project deliverables; coordinating, tracking and reporting on validation status throughout the entire validation lifecycle.
Organize and direct cross-functional and cross-site relationships with Manufacturing, technical support groups, and R and D for problem resolution and validation optimization.
Ensure validation follows a lifecycle approach from URS development through equipment retirement.
Ensure the validated state of equipment, systems, and processes are maintained through periodic review and revalidation programs.
Provide validation input and assessment for Annual Product Quality Reviews.
Work closely with Manufacturing, technical support groups, and QA to thoroughly investigate validation discrepancies. Lead and participate in root cause analyses to resolve validation deviations.
Collaborate with departments to ensure validation activities are executed efficiently and effectively, and in accordance with all governing documents and external guidelines.
Manage competing priorities and allocate and optimize assigned department resources to ensure targets and timelines are met.
Serve as a subject matter expert (SME) in support of department functions. Develop, mentor, and train personnel and internal customers on relevant business processes.
Ensure changes have the appropriate level of technical assessment and approval.
Participate in external vendor audits.
Provide input into the design and presentation of department performance metrics.
Contribute to continuous quality improvement efforts to conform to regulatory requirements and industry standards. .
Qualifications: Education, Experience, Knowledge and Skills:
B.A. or B.S. degree, and at least 7 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience
Sound knowledge of cGMPs or equivalent regulations
Ability to interpret and relate quality standards for implementation and review
Ability to make sound GMP decisions, allocation of resources, and managing priorities
Ability to communicate clearly and professionally both in writing and verbally.
Flexibility in problem solving, providing direction and work hours to meet business objectives.
Ability to work independently and cross functionally in a dynamic environment
Direct people management experience required
Illumina, Inc. - 2 years ago
Illumina elucidates the human genome. The firm makes tools used by life sciences and drug researchers to isolate and analyze...