Manufacturing Operations Specialist
5 days ago
- This role involves providing technical support, leading cross-functional teams, and liaising with vendors and site groups. Prior experience in manufacturing, preferably GMP, and knowledge of process monitoring and automation systems are desirable.
- Design, review, and approve qualification and validation documentation, including process development studies.
- Develop and execute change controls and support continuous improvement initiatives.
- Contribute to Kaizen events and provide technical input into investigations.
- Support equipment qualification, re-qualification, and re-validation programs.
- Perform root cause analysis to resolve system failures and issues.
- Represent technical operations in internal and global forums.
- Ensure compliance with global policies, cGMP, and regulatory requirements, including documentation and audits.
- Promote a safe and compliant work culture.
- Bachelor's Degree in Science, Engineering, or a related technical field.
- At least 3 years of experience in manufacturing, preferably GMP.
- Proven experience leading technical projects.
- Knowledge of process monitoring, automation systems (DeltaV), and data systems (Pi System) is advantageous.
- Understanding of regulatory standards and equipment validation.
- Proficiency in Microsoft Office and related applications.
- Excellent communication and interpersonal skills.
- Willingness to support hybrid roles and occasional shift work.
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