Job Responsibilities
1. Includes, but not limited to, execution of the following activities for the relevant systems in accordance with project procedures/guidelines.
2. System Boundary development and approval.
3. Design Qualification preparation, execution and approval. Includes release for IQ.
4. GMP-RA’s.
5. Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
6. Installation Qualification preparation, execution and approval. Includes release for OQ.
7. Operational Qualification preparation, execution and approval. Includes release to OPS.
8. Provide support in execution of Design Qualification for other direct impact systems.
9. Provide support in the implementation of the Installation Commissioning process in accordance with project procedures/guidelines.
Minimum Requirements
1. Bachelor’s degree in Life Sciences or Engineering.
2. Solid experience in commissioning and qualification.
3. Experience with DeltaV (Emerson) and other Control Systems.
4. Experience with COMOS/KNEAT platforms.
5. Fluent English language written and verbal communication skills.
6. CGMP knowledge and knowledge of regulatory requirements.
7. Able to work with minimum oversight fulfilling deliverables within target dates.
Benefits
1. Be part of an innovative and industry-leading company.
2. Work with a dedicated and supportive team.
3. Opportunities for personal and professional growth.
4. Competitive salary and benefits package.
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