ITAAN PHARMA
Location
Secunderabad | India
Job description
UTILITY SYSTEMS ENGINEER
Company Description
We develop and commercialize injectable products for regulated markets; our primary commercial operations are in the US and Canada. ITAAN applies science-based product lifecycle management approaches to maintain market competitiveness.
Role Description
This is a full-time on-site role as a Utility Systems Engineer for our injectable manufacturing facility, reporting to Senior Manager, Engineering, Maintenance & EHS at ITAAN PHARMA in Hyderabad. The Utility Systems Engineer will lead utility systems-related activities at our injectable manufacturing facility. The Utility Systems Engineer will work cross-functionally to design, maintain compliance, troubleshoot and mitigate issues related to utility systems.
Responsibilities
- Oversee the operation, maintenance, and monitoring of utilities such as Purified Water (PW), Water for Injection (WFI), Pure Steam generation and distribution systems, compressed air, process gasses, chilled water.
- Lead and participate in the qualification processes for utility systems, ensuring compliance with regulatory standards.
- Develop and maintain an annual preventive maintenance (PM) schedule and calibration plan for the Utility Systems.
- Prepare and revise Standard Operating Procedures (SOPs) for Utility Systems as needed, ensuring documentation reflects current practices.
- Collaborate with the validation and operational teams to complete periodic qualifications, facilitating seamless coordination and communication.
- Demonstrate expertise in Quality Management System (QMS) elements, ensuring adherence to quality standards and regulatory requirements.
- Establish procedures for timely acknowledgment and response to alarms, including the escalation process for critical alarms and documenting and trending alarms.
- Oversee the configuration and setup of alarm systems for utility systems, ensuring proper thresholds and parameters are defined.
- Ensure that data generated and recorded by utility systems comply with data integrity standards and regulatory requirements.
- Take responsibility for reviewing and approving critical data records to ensure accuracy and reliability.
- Monitor and trend utility process and quality parameters, implementing proactive measures to maintain optimal system performance.
- Play a key role in customer and regulatory audits, showcasing comprehensive knowledge and involvement in utility systems.
- Continuously assess and improve utility systems processes, incorporating industry best practices and staying abreast of technological advancements.
- Provide technical guidance and training to the operational team, fostering a culture of excellence and compliance within the utility systems domain.
- Actively contribute to cross-functional teams, collaborating with various departments to ensure seamless integration of utility systems with overall facility operations.
- Act as a point of contact for utility systems-related inquiries, addressing and resolving issues promptly to minimize downtime and disruptions.
- Create and maintain detailed utility layout drawings that accurately represent the placement of equipment, pipelines, and control points.
- Foster a safety-first culture by implementing and promoting safety protocols within the utility systems environment.
Qualifications
- BTech degree in Engineering, preferably in Chemical, Mechanical, or a related field.
- 6-8 years of relevant experience overseeing and managing utility systems in sterile processing working with a US FDA-approved organization.
- In-depth understanding of regulatory standards and guidelines for utility systems in regulated industries.
- Familiarity with Quality Management System (QMS) elements and a commitment to ensuring compliance with quality standards.
- Strong communication and collaboration skills to work effectively with cross-functional teams, provide technical guidance, and act as a point of contact.
Job tags
Salary
