Ll02-250822 - Cqv Lead [Facilities & Utilities]
Validation & Engineering Group
- Gurabo, PR
- Permanente
- Tiempo completo
Provide a list of potential gaps, opportunities for alignment of efforts and opportunities to leverage construction quality verifications into commissioning and qualification.
Determine whether the definition and timing of system handover as well as the timing of system turnover packages is sufficient to support the C&Q plan.
Develop and obtain approval of document templates.
Ensure that quality documents are produced.
Ensure that the deliverables are developed in the proper sequence, to the appropriate level of detail and with the expected quality.
Develop and track execution plans with Class Staff.
Communicate progress on an established team meeting schedule; promptly escalating any challenges/delays that may require additional support to resolve and remain on schedule.
Initiates change controls and document changes/creation as necessary.
Supports generation of validation and support documents (SOP's, Configuration Specification, etc.).
Executes validation protocols against systems as necessary.Requirements:Have substantial experience with integrated commissioning and qualification programs, and aseptic fill/finish facilities.
Ten (10) or more years preferred in a aseptic pharmaceutical manufacturing role with SME status in multiple Validation disciplines.
Bachelor's degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and cGMPs.
Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity.
Experience in C&Q of New classified and non-classified production areas and support areas
Experience in room qualification, disinfection efficacy and smoke studies.
Experience in C&Q of: WFI, clean steam, process gases, HVAC and associated classified spaces, Warehouse.
Experience in DQ, IQ, OQ, PQ.
Experience in enhanced commissioning/ leverage approach qualification efforts.
Experience working with Kneat.
Ability to work independently while maintaining communication with all team members.
Requires teamwork, leadership, and influencing skills with a strong focus on customer service.
Excellent communication skills, both written and verbal, are required.
Working Conditions
The incumbent will be required to work in an office environment potentially requiring ergonomic considerations.
The incumbent will be required to work in a conference room environment for moderate periods of time.
The incumbent will be required to work with computers for up to 8 hours per day, including typing and viewing computer screens during this time.
Occasional excursions to labs, production area or warehouse requiring some level of gowning.
Exposure to typical manufacturing, laboratory, mechanical and warehouse environments.
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