What are the responsibilities and job description for the Calibration Lead position at Aveva Drug Delivery Systems?
Description
Strategic Leadership & Vision
Strategic Leadership & Vision
- Develop and execute the engineering strategy for the Tamarac site aligned with site objectives, operational excellence, and technology enhancements.
- Lead cross-functional initiatives at the site to support capacity expansion, equipment modernization, and continuous improvement.
- Serve as the senior engineering leader at the facility and provide directions on all major technical decisions.
- Lead all calibration related activities in capital project activities at the Tamarac site, including design, infrastructure upgrades, and equipment installations.
- Ensure accurate project scoping, budgeting, scheduling, and stakeholder alignment for new facility builds, renovations, and clean utility improvements.
- Guide the engineering design for GMP manufacturing areas including sterile, non-sterile, and controlled substance environments.
- Oversee the selection, installation, and qualification of new manufacturing and packaging equipment, including process equipment’s, and automated packaging lines.
- Provide engineering support for the introduction and scale-up of new products and technologies from R&D to commercial operations.
- Champion digital transformation and automation enhancements to support increased efficiency and compliance.
- Ensure all engineering activities at the Tamarac facility are compliant with FDA, EMA, DEA, and internal quality standards.
- Provide support for the qualification and validation of equipment, and facility systems.
- Maintain strict DEA compliance for facility design, storage, and access control of controlled substances.
- Ensure engineering readiness for audits and inspections and lead resolution of any related findings.
- Collaborate with Quality and Compliance teams during audits and inspections.
- Direct maintenance and reliability programs for all site assets including process equipment, and packaging systems.
- Implement and optimize preventive and predictive maintenance practices.
- Ensure high asset reliability and reduce downtime through robust engineering support and continuous improvement.
- Ensure engineering designs, equipment installations, and process changes incorporate EH&S risk assessments and mitigation plans.
- Collaborate with EHS teams to support compliance with local and national environmental and safety regulations.
- Ensure strict adherence to safety protocols and regulatory requirements in all engineering operations.
- Conduct routine safety audits, hazard assessments, and risk evaluations within BFS facilities.
- Promote a culture of safety through training, audits, and continuous improvement in workplace safety systems.
- Build, lead, and develop a high-performing engineering and maintenance team at the Tamarac facility.
- Foster a culture of innovation, accountability, and collaboration.
- Coordinate with the engineering team to troubleshoot and resolve technical issues swiftly during shifts.
- Mentor technical talent and provide career development opportunities.
- Recruits, trains, develop and manage effectively the ongoing performance of their direct reports, which includes, but is not limited to:
- Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes.
- Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy.
- Effectively managing performance for direct reports according to the Performance Management Program,
- Oversee shift-wise engineering operations, ensuring smooth and uninterrupted production.
- Implement shift rotation plans to ensure optimal resource utilization and compliance with labor laws.
- Attracting and retaining talent based on our talent management framework.
- Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions.
- Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
- Responsible to ensure compliance of team members (direct reports) with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.
- Works as a member of a team to achieve all outcomes.
- Leads with a mindset that respects all cultural dimensions.
- Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and
- All other duties as assigned.
- Associate's degree in engineering and 10 years of pharmaceutical GMP experience or a Batchelor's degree in engineering and 7 years of pharmaceutical GMP experience.
- 10 years of progressive engineering leadership experience in pharmaceutical manufacturing, with at least 3 years at an executive level.
- Proven experience managing engineering for pharmaceutical manufacturing, aseptic experience preferred.