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Engineering CoordinatorApply Now
As Engineering Coordinator you will be responsible for Coordination, planning, execution and reporting of Site Engineering tasks related to changes and Deviations within the Site Engineering department (Maintenance, Process Engineering, Validation Engineering, Automation, Facility & Utility Engineering, Facility Services/IFM and Capital/Project Mgmt ). The role responsibility covers Open changes & deviations, coordination of SMEs changes assessments and deviations investigations, management of KPIs related to changes & Deviation, Site Engineering representative for changes and Deviations.
As Coordinator you will have an active involvement in Changes & deviations management, development and implementation of new initiatives. You will assure issue resolution arising from Engineering activities in cooperation with Engineering Guideline, Quality, and Manufacturing.
The role is expected to have a solid understanding of industry standards and Engineering compliance requirements.
The Coordinator performs, troubleshoots and supports the Engineering activities. He/she performs a variety of activities to support changes implementation and CAPAs. He/she represents the Site Engineering on Changes and CAPAs Boards and interfaces with peers in various other departments such as Quality and manufacturing to ensure that changes and deviations related to Engineering activities are conducted according to established quality standards.
Essential Duties & Responsibilities :
- Maintain and develop expertise in Changes control and deviation management according to Takeda and Regulatory standards
- Write, review and approve changes and deviations documents (Investigations...etc.) according to Takeda and Regulatory standards
- Participate in Changes and deviation activities from initiation, execution, effectiveness check to closure
- Coordinate and follow-up deviations and Changes execution, ensuring that all Engineering activities and documents are completed and documented in a timely manner.
- Provide support related to problems solving, root cause analysis, CAPAs investigation and implementation steps
- Participate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on time
- We are looking for a strong energetic team player with good communication skills,
- Demonstrated interpersonal and expertise skills with ability to interface well with other departments, and lead effectively and efficiently engineering topics
- Ability to manage multiple priorities in a manufacturing plant setting
- Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
- Interpersonal skills that enables you to work with people at all levels
- Ability to plan, multitask, and manage time effectively
- Must display personal accountability for results and integrity
- Must display eagerness to learn, to innovate, drive for solutions and continuously improvement
- Engineering degree or equivalent, preferably with Engineering background
- At least 5 years’ experience in the pharmaceutical/biotechnology industry
- cGMP and Engineering skills
- Broad Engineering knowledge, industrial trends and Engineering related literature
- Solid computer skills including Word, Excel, PowerPoint.
- Very good French level (oral and written)
- Very good English level (oral and written)
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0043234