Within this role you will perform 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, organize the purchase, delivery & installation of cleanroom furniture and storage, liaising with external vendors, lead / support Manufacturing projects relating to small equipment introduction, qualification etc.

Performs people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring, terminations, and performance evaluations.

As an Assoc / Manufacturing Equipment Specialist, a typical day may include, but are not limited to, the following :

This is a straight days position, Monday - Friday.

The qualification of small equipment by liaising with multiple vendors, review and sign-off of qualification packages, completing BMRAM activities including ECN builds and PM event builds for multiple pieces of equipment.

Generation of System Impact Assessments and System Requirement Specifications for new equipment and update old equipment SRS / SIA.

Defining standards, controls, and procedures across the lifecycle of documents.

Contact external vendors to come on site, organize induction, organize safe permit for work and supervise and approve vendor works.

Review vendor Method Statements & Risk Assessments. Liaise with EHS regrading having these approved.

Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.

Leads and coordinates equipment qualification projects from initiation to completion.

Applying standards, controls, and procedures across the lifecycle of documents.

Support / lead small manufacturing projects as / when required.

Support NPI.

Manages Implementation of supplemental qualification to existing systems.

Performs 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 :

Strong analytical skills with the ability to collect, organize, analyze, and disseminate information with attention to detail and accuracy.

Background in equipment qualification is preferred.

Can work both independently as an original thinker and in a team setting.

Strong communication skills and leadership skills.

Level commensurate with experience

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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Last updated : 2024-05-27