Qualification Specialist/Engineer – Production Equipment (Pharmaceutical Solid Forms) - 6-months contract
Join to apply for the Qualification Specialist/Engineer – Production Equipment (Pharmaceutical Solid Forms) - 6-months contract role at AurigaVision AG.
This role involves overseeing qualification activities for the revamping of the tableting manufacturing area, including Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Equipment Qualification, Handover, and Project Close-Out.
Responsibilities include:
* Providing oversight of site commissioning and qualification activities supporting capital projects.
* Leading activities focused on commissioning and qualifying OSD process equipment and Computerized System validation.
* Managing C&Q work activities to ensure timely and within-budget completion.
* Driving qualification activities according to company standards and regulatory requirements.
* Collaborating with multiple departments and sites to provide technical guidance.
* Designing and authoring validation/qualification plans, protocols, and reports.
* Leading complex investigations, change controls, and corrective actions related to C&Q activities.
* Implementing structures, tools, and processes to manage C&Q activities.
* Participating in internal and external audits as a Subject Matter Expert (SME).
Your profile:
* Degree in Engineering or Science (e.g., life sciences, Mechanical, Chemical).
* Minimum 5 years of relevant pharmaceutical industry experience, especially in OSD pharmaceutical validation within a GMP environment.
* Experience managing complex projects for at least 5 years.
* Strong problem-solving, communication, and interpersonal skills.
* Ability to work independently and across organizational boundaries.
* Fluent in English and French.
* Experience with Product Lifecycle Management and health authority inspections.
Application documents (CV, diploma, references) should be submitted via our job portal. No motivational letter is required. Full discretion guaranteed.
Additional details:
* Seniority level: Associate
* Employment type: Temporary
* Job function: Product Management
* Industry: Pharmaceutical Manufacturing
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