Sr. Director, Facilities & Engineering

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeReporting to the Vice President & General Manager the Sr. Director of Facilities and Engineering is responsible for a staff of engineers automation metrology staff and validation personnel with expertise in aseptic/ sterile drug product formulation vial and syringe filling and primary packaging manufacturing activities for liquid and suspension products. The Sr. Director of Facilities and Engineering leads and enables the team to conduct oversight of the three St. Louis manufacturing sites and the GMP warehouse to support internal and external / client role assures strategic alignment to site vision strategic and operational plans to assure achievement of site and business objectives. As part of the site leadership team the leader assures clarity alignment and direction is provided to the Facilities and Engineering teams and with partner functions; plans forecasts and manages resources to support demand and requirements for all engineering related activities; and collaborates with other functions across the site and within the network to develop required facilities and engineering solutions include equipment reliability and spare parts Facilities and Engineering Sr. Director serves as the system owner for multiple quality systems including but not limited to equipment validation preventative maintenance calibration and overall capital planning and maintenance of the St. Louis campus. The Sr. Director of Facilities and Engineering fosters an environment that encourages innovation with respect to identification evaluation and implementation of new technologies new products and improvement to existing commercial products and continually partners across functions to assure the site stays a member of the Site Leadership Team (SLT) sets goals for both site and direction and prioritization for the functional area managers within the F&E department. Hires and develops employees and creates succession plans. Provides feedback and coaching and performance tactical execution of operational activities across the Engineering functional groups and for the site as a member of the SLT. Communicates to stakeholders issues and resolutions in a timely and meets customer commitments including new product introduction timelinesIdentifies opportunities to improve robustness reliability and other aspects of operational performanceProvides Engineering expertise at site and across sites. Supports strategic business activities including long range planning S&OP capital investment plans facility master plans due diligence and other governance operational budget and partners with key stakeholders to plan and manage capital investmentsRepresents Kindeva St. Louis in external interactions with regulatory agencies customers government agencies business partners and service adequate training (skills-based cGMP and Safety) of employees within department to perform or exceed job and maintains relationships with other Kindeva engineering teams to develop and promote engineering best practicesQualifications15 years of related experience in the Pharmaceutical or related industry including experience in engineering operations and project management.10 years of experience in a functional leadership position within one or more areas including Process Engineering Facilities/Engineering Maintenance Automation Validation or related functionsExperience in building own team and project teams and developing teams capabilities to deliver resultsDirect experience supporting manufacturing facilities and utility systems within an FDA/EMA regulated understanding of applicable regulatory requirements (FDA and EMA). Audit experience is knowledge of GMP equipment utility and cleanroom design/installation and quality control laboratory design/installationStrong understanding of industry standards for commissioning validation and operation of facilities and utilities for cGMP manufacturing and GxP laboratoriesExperience with single-use technologies is preferredExperience with a GMP facility startup is preferred#LI-ON-SITE