Job Description
The Manufacturing Equipment Specialist performs tasks related to the set-up and start-up of manufacturing operations (Large Scale & Sub-Suites); primarily, the qualification of Manufacturing Small Equipment, review and approval of equipment qualification packages, purchase, delivery & installation of cleanroom furniture and storage, liaising with external vendors, lead/support projects relating to small equipment introduction and qualification.As a Manufacturing Equipment Specialist, a typical day may include, but is not limited to, the following:Qualifying small equipment by liaising with multiple vendors, reviewing and signing off of qualification packages, completing BMRAM activities including ECN builds and PM event builds for multiple pieces of equipment.Generating System Impact Assessments and System Requirement Specifications for new equipment and updating old equipment SRS/SIA.Defining standards, controls and procedures across the lifecycle of documents.Contacting external vendors to come on-site, organizing induction, organizing safe permit for work and supervising and approving vendor works.Reviewing vendor Method Statements & Risk Assessments and liaising with EHS regarding approvals of same.Interfacing with other departments such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.Acting as equipment SME with respect to data integrity, audit and managing upgrades.Implementing data integrity requirements within project documentation.Leading and coordinating equipment qualification projects from initiation to completion.Applying standards, controls, and procedures across the lifecycle of documents.Supporting and leading small manufacturing projects when required.Supporting NPI.Managing implementation of supplemental qualification to existing systems.Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations and performance evaluations.The role may be for you if:You have a background in equipment qualification.You have strong analytical skills with the ability to collect, organize, analyze and disseminate information with attention to detail and accuracy.You can work both independently as an original thinker and in a team setting.You have strong communication skills and leadership skills.To be considered for this opportunity you should have a BS/BA/BEng in a technical discipline, with 2+ years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience. #J-18808-Ljbffr