Associate Director, Engineering- Validation

Job Description

Job Description:

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, manufacturing plants and offices that are designed to inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of vaccines and biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Validation organization at our Durham, North Carolina facility is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate with their colleagues in other areas of the organization, as well as all areas of their primary support facility (i.e. Sterile Supply, Lyophilization, and Filling) and cross-functional teams (i.e. Tech Ops, Maintenance, Quality, Automation, and Operations) to ensure a successful Validation support of the vaccine manufacturing facilities.

The Associate Director, Validation will be responsible for providing Validation leadership as part of the Vaccine Manufacturing Facility's Validation team within the Technical Operations organization.

Position Responsibilities:

• Reporting to the Director, Validation the incumbent will lead the team of validation engineers responsible for Validation activities in all areas of the facility.

• Effectively manage a team of Validation engineers by maintaining a culture that defines a High-Performing Organization including proactively providing developmental support, coaching, and assistance to team members.

• Responsible for all Human Resource activities including one-on-one meetings, team development, hiring, talent assessment, and performance reviews.

• Responsible for the facility requalification program, ensuring execution and closeout of requalification activities in accordance with the requalification plan and corporate guidelines.

• Manage supplemental contracted Validation partners and strategically balance the team structure to support project scope changes and priorities.

• Manage the proposals, budgeting, and forecasting needs for the contracted validation partners.

• Prioritize team safety, environmental, and compliance objectives.

• Lead, facilitate, and participate on cross-functional teams to collaboratively address issues and achieve milestones.

• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

• Author, review, and/or edit technical documents to support regulatory filings

• Author and approve validation procedures in accordance with our Company guidelines

• Support both internal and regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors as needed.

• Act as a validation subject matter expert in support of quality risk assessments and regulatory inspections.

• Partner with other area Validation leads to for alignment, organizational strategy, and opportunities to provide support across the areas.

• Deliver validation-related projects, including planning, protocol generation, execution, and summary of results in technical reports.

• Manage timely implementation and closeout of validation deliverables to meet production and supply timelines.

• Stay abreast of current trends in industry and innovate to drive continuous improvement.

• Represent the site in internal collaborations through our Manufacturing Division Validation Communities of Practice to include the sharing of best practices in validation and investigation activities.

• Support creation of departmental budget and monitor actual performance against the forecast.

Required Experience and Skills:

• Bachelors, Masters or Doctorate degree in chemical engineering, biochemical engineering, biological systems engineeri