Senior Engineer
1 month ago
BioPharma Consulting JAD Group is seeking a Senior Engineer to join our team. The Senior Engineer will need to have strong hands-on experience and a solid technical background in engineering and mathematics. The ideal candidate will possess practical troubleshooting skills and the ability to engage in technical conversations. This is an exciting opportunity to work with industry leaders and contribute to the development of life-saving medicines and therapies.
Responsibilities:
- Lead and manage engineering projects from conception to completion.
- Assist in identifying critical quality parameters and process attributes for new equipment or facility modifications.
- Develop the commissioning strategy based on User Requirements Specifications (URS) and Quality Risk Assessment for
- Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact.
- Troubleshoot operational issues and provide technical expertise to ensure manufacturing efficiency and quality
- Oversee the development of validation protocols in line with Critical Quality Parameters (CQP), Automation Systems Delivery SOPs, and cGMP standards.
- Ensure all work is executed with safety-compliant practices and documented in accordance with cGMP good documentation practices.
- Act as a liaison between engineering and quality assurance during project planning, execution, and closeout.
- Be accountable for the reliability of manufacturing equipment and deliverables on key capital projects, ensuring alignment with business targets and objectives.
- Recommend, evaluate, and manage the performance of contract resources. Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Review and approve commissioning reports, maintenance practices, and parts, driving productivity improvements.
Requirements:
- Bachelor's degree in Engineering or related field
- Minimum of 5 years of experience in the pharmaceutical or biotech industry
- Strong knowledge of pharmaceutical/biotech processes and validation processes
- Experience with documentation in a highly regulated environment
- Proficiency in using engineering software and tools
- Excellent analytical and problem-solving skills
- Strong communication and interpersonal skills
- Ability to work independently and collaboratively in a team environment
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