The Opportunity

Reporting to the Sr. Manager of Maintenance, provides managerial direction and technical leadership for all site instrumentation and calibration activities. Responsibilities include financial and work order tracking and reporting, ensuring compliance with Seqirus quality standards, and managing and developing staff.

Location: on-site in Holly Springs, NC

The Role

• Provides strong leadership and organizational planning skills. Responsible to mentor and development staff.

• Provide technical expertise and oversight of assigned discipline to staff.

• Communicate (written and oral) with internal staff and external stakeholders. Interfaces across management levels and departments.

• Manage vendors and contracts including system vendors and contract staff.

• Implement maintenance and service programs consistent with cGMPs, industry best practices, and internal Seqirus Policies and Requirements.

• Ensure all areas of responsibility are in compliance with all applicable GxP regulations/requirements and in a state of inspection readiness.

• Audits and maintains processes for documentation accuracy and completeness. Ensure determination of Root Causes and determine appropriate Corrective Action(s) for the department assigned discrepancies and audit observations. Support investigations related to critical instrumentation.

• Present maintenance, processes and data to Regulatory Agencies, Customers or Partners during inspections.

• Provide leadership to Maintenance staff and provide ongoing staff development for an effective and cost efficient department.

• Ensure effective scheduling and schedule adherence for all equipment/ system PMs, calibrations and repair activities consistent with approved SOPs.

• Lead and ensure successful execution of Plant Shutdowns and upgrade projects as assigned.

• Maintain a safe work culture and ensure that staff is trained on appropriate policies and practices.

• Provide direction for maintaining and operating all physical equipment and facilities to ensure its proper use.

• Draft efficient maintenance procedures for all process and plant maintenance equipment, providing troubleshooting expertise in all areas of plant operations and maintenance.

• Maintain and progressively improve the site Preventive Maintenance Program.

• Maintain and manage data for instrumentation and calibrations for site CMMS.

• Maintain open lines of communication between departments and employees.

• Direct and/or assists in the design and execution of small capital projects.

Your skills and experience

Education

• Bachelor’s degree required (Engineering or Science discipline preferred) with 5 years of experience or 7 years of relevant experience with no advanced degree.

Experience

• 3 or more years of demonstrated leadership of staff or projects in technical or engineering field required.

• Minimum of 7 years’ experience in pharmaceutical/biotech engineering operations or regulated industry preferred.

• Demonstrated knowledge of assigned discipline; build knowledge of other maintenance disciplines.

• Experience with CMMS systems and inventory systems required (SAP preferred)

Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

Do work that matters at CSL Seqirus!

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus