Production Equipment Qualification Engineer
Production Equipment Qualification Engineer
SII Group is a trusted technology partner, SII provides high value added solutions for the IT projects of many large corporations. Since its founding in 1979, the Company has been providing solutions adapted to its clients’ needs, by relying on :
> Its acknowledged expertise in various industries and sectors
> Proven 'turnkey' solutions
> Adaptable, evolving services
Today, with a staff of more than 18'000, SII Group is supporting companies across 20 countries.
At SII Switzerland we pay attention to the personal and professional wellbeing of our employees. We place our collaborators at the heart of our actions and activities. If you are motivated by the perspective of joining a big, trusted and recognized group, then let's meet !
To develop our consulting offer and support one of our clients, we are looking for a Production Equipment Qualification Engineer.
Missions
* Provide oversight of the site commissioning and qualification organization in support of capital projects
* Lead the activities focused on commissioning and qualifying OSD process equipment, Computerized System
* The individual oversees the C&Q work activities of low to major complexity to ensure on time and within budget completion
* Responsible for driving the commissioning and qualification activities of the tableting area a (incl. equipment CSV..) according to the company standards and regulatory requirements
* Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
* Interface with multiple sites and departments (engineering, technical services, MS&T, end user groups, QA, suppliers, and C&Q contractor) to accomplish predefined goals and to provide technical guidance including but not limited to production OSD equipment, automation, and Computerized System validation
* Design and author the validation/qualification approach, provide the scientific rationale and acceptance criteria, generate and review/approve commissioning, validation/qualification protocols/reports
* Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing
* Lead/support the completion of complex investigations, initiate change controls (incl. assessing impact of the change) and managing corrective action plans associated with C&Q activities
* Lead/Support the implementation of structures, tools, and processes to actively manage C&Q activities
* Participate when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation
Profile
* Degree in Engineering or Science related discipline performed
* 5 years of relevant pharmaceutical industry experience (with a focus on OSD pharmaceutical application validation in a GMP environment)
* Experience in managing complex projects
* Project and change management experience
* Experience with Product Life Cycle Management
* Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face to face interaction and response to audit questions
For information
* Duration : Long term
* Language : Fluent in English and French
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Consulting
* Industries
IT Services and IT Consulting
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