C&Q Process Lead

U326

&Q Process Lead for a new vaccine fill/ finish facility within an existing building on a site that had not performed secondary filling for over 10 years. Provided manufacturing/ process leadership and technical support during the project. Long lead time equipment had been ordered and the role ran from DQ through FAT, SAT, IQ to OQ. Where I am currently I am currently transitioning to the site staff member who will be responsible for running the facility during OQ through to commercial operation

Category:
Engineer Commissioning & Qualification
Location:
Sweden
Years of Experience Req.:
Proven qualifications and experience
Date Posted:
05/10/2020
Days Remaining:
64
Employment Type:
Contract
Education Level Req.:
Proven qualifications and experience

Skills & Abilities

WORK PACKAGES

 

•        C&Q Process Lead for a new vaccine fill/ finish facility within an existing building on a site that had not performed secondary filling for over 10 years. Provided manufacturing/ process leadership and technical support during the project. Long lead time equipment had been ordered and the role ran from DQ through FAT, SAT, IQ to OQ. Where I am currently I am currently transitioning to the site staff member who will be responsible for running the facility during OQ through to commercial operation. Main aspects of role were to set up all manufacturing systems, procedures and processes. Perform all risk assessments for process (process, sterility, equipment and product). Perform detailed review and gap analysis of all filling line equipment ordered to ensure it meets regulatory requirements and process needs. Support all C+Q activities for the filling line. This includes all aspects, input into qualification strategy and planning, generation, review and approval of all protocols and reports. Review and approval of all vendor design documentation FS, SDS, HDS, P&IDs etc.

•        Project Support for design for a new facility in design build stage. Performed a design review and criticality assessment in detailed design for the major equipment items for containment compounding and formulation in a sterile API facility. 

•        Production Management and Project Work Stream lead for the completion of the Commissioning and Qualification (C&Q) phase, through Performance Qualification, Process Validation (PV) to license submission for a greenfield secondary biological sterile injectables fill/ finish facility that includes a variety of technologies including an integrated filling line incorporating isolator technology and lyophilisers with an automated loading/ unloading system. This involved leading the production department and coordinating all departmental, functional and cross-functional working within the facility to ensure that the facility

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