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.
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