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Automation Validation Specialist
2 months ago
At BioSpace, Inc., we are dedicated to enhancing the quality of life through innovative healthcare solutions. Our team is committed to discovering and delivering transformative medicines that address the needs of patients globally.
About Us
BioSpace, Inc. is at the forefront of the healthcare industry, focusing on the development of cutting-edge manufacturing capabilities for Active Pharmaceutical Ingredients (APIs). We are excited to expand our operations and are seeking talented individuals to join our pioneering team.
Role Summary
As an Automation Validation Specialist, you will be integral to ensuring the compliance and reliability of computerized systems within our API manufacturing facility. This role is essential in supporting the Process Automation team and will involve leading and executing validation activities for automation systems across our operations. You will collaborate with various teams, providing your expertise in validating systems that are crucial for the production of life-enhancing products.
Key Responsibilities:
- Contribute engineering insights to Commissioning and Qualification and Data Integrity initiatives.
- Review or create documentation related to the Software Development Lifecycle (including VP, URS, FRS, FS, DS, etc.).
- Develop and implement Validation Plans, Strategies, Trace Matrices, and Test Protocols/Cases (IQ/IV, OQ/OV, PQ) for DCS, PLC, DDC, and PAT systems.
- Conduct periodic assessments of qualified/validated Automated Systems (Process Control and Automated Equipment).
- Lead or assist in remediation efforts, including Qualification/Validation activities to address identified gaps.
- Identify Data Integrity issues and propose effective solutions.
- Participate in the community of practice for Data Integrity and CSV programs.
- Evaluate emerging technologies for potential integration to meet data integrity standards.
- Establish and execute best practices and standards to support manufacturing and major capital project delivery.
- Collaborate globally with other manufacturing sites to share and implement best practices.
- Prioritize safety and continuously seek improvements for both personnel and equipment safety.
- Bachelor's degree in Engineering, Computer Science, or a related field.
- Minimum of 3 years of experience in leading or supporting Commissioning and Qualification strategies for Automated/Computerized manufacturing systems.
- At least 3 years of experience with process automation platforms (e.g., DeltaV, Rockwell, Johnson Controls).
- 2+ years of experience in a cGMP regulated environment (API, Pharma, or Medical Devices).
- Thorough understanding of ISA Standards S88/S95.
- Expertise in preferred platforms, including Rockwell Factory Talk, Siemens, Johnson Control, Aveva PI, and Microsoft Operating Systems.
- Knowledge of Historians and IT platforms such as servers and workstations.
- Strong technical writing capabilities.
- Commitment to maintaining a safe working environment for oneself and others.