Sr. Manager, Validation

Role Summary

Lead the Commissioning, Qualification and Validation (CQV), Cleaning, Sterility assurance and Computer System Validation (CSV) teams at a site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and global validation initiatives as needed.

Responsibilities

• Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks
• Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints
• Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.
• Continuously improve the culture of the Validation team and the site
• Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)

Responsibilities

• Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
• Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
• Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
• Direct support to OST head or lead annual OPEX budget for Validation department

Responsibilities

• Effective delegation and building confidence and competence within direct reports
• Drive engagement in the technical and personal development of the Validation team and members
• Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
• Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives
• Continuously improve the culture of the Validation team and the site

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Qualifications

• BS in Engineering, Science, Management, or equivalent experience
• A minimum of 8 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 3 years in a leadership role
• Significant hands on experience and regulatory expectations knowledge with controls, automation and computer system validation.
• Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, CIP skids, autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage, and distribution, RODI water system, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage
• Strong track record of researching industry best practice (ISPE, BPOG, etc.) and partnering with engineering firms and consultants to develop and deliver effective and compliant projects

Additional Requirements

• If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled.