Director, Facilities and Engineering
$175k - $200kEdmond Pharma S.R.L.
We are seeking an experienced and strategic Director or Facilites and Engineering to lead a multidisciplianry orgnaization responsible for facilities operations, engineering, maintenance, metrology/calibration, commissioning/qualification/validation (CQV), automation, and site IT infrastructure. In this critical role, you will ensure the uninterrupted operation of GMP plant systems, maintain compliance with regualtory data and integrity standards, and drive operational excellence across all infrastructure and technical functions. You will play a key role in enabling manufacturing readiness, supporting business growth, and delivering reliable, compliant, and scalable operations. MAIN TASKS & RESPONSIBILITIES Develop and implement stategic direction for Facilities, Engineering, Maintenance, Metrology, CQV, Automation, and IT functions to support operational reliability and business objectives. Ensure continuous, compliant operation of GMP manufacturing equipment, utilities, facilities, automation systems, and infrastructure. Oversee preventative maintenance, calibration/metrology, CQV, automation, and computerized systems programs, driving continuous imporvement. Lead commissioning, qualification, and validation activities for new equipment, facility expansions, and system changes. Direct automation and IT initiatives, including system upgrades, integrations, data integrity, and cybersecuirty coordination. Manage site IT infrastrucutre and operational technology (OT) systems to ensure security, reliablity, and compliance. Collaborate cross-functionally with Manufacturing, Quality, Process Development, Supply Chain, and Validation teams to support production and continuous imporvement. Oversee external contractors, vendors, and system integrators to ensure safe, compliant, and high-quality execution of projects. Provide technical leadership, coaching, and guidance to ensure adherence to cGMP, data integrity, and cybersecurity requirements. Lead change managment processes for facility, equipment, automation, and infrastructure modifications. Develop and approve SOP's, engineering standards, validation documents, and technical documentation. Plan, prioritize, and deliver capital projects and infrastructure initiatives to support business growth. Manage departmental operating and capital budgets, forecasting, and resource allocation. Build and lead a high-performing, multidisciplinary team, fostering a culture of safety, accountability, and continuous imporvement. SKILLS AND EXPERIENCE Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or related technical field (Masters or MBA preferred) 10+ years of progressive leadership experience in a GMP-regulated manufacturing environment (biotech, pharmaceutical, or life sciences preferred). Demonstrated leadership experience across Facilities, Engineering, Maintenance, Metrology, CQV, Automation, and/or IT functions. Strong knowledge of cGMP requirements, quality systems, CQV practices, automation/computerized systems, and data integrity principles. Proven experience managing captial projects, facility expansions, and infrastrucutre upgrades. Expertise in leading cross-functional teams and influencing stakeholders across operations, quality, and executive leadership. Experience managing operating and capital budgets, strategic planning, and resource allocation. Strong leadership, coaching, and organizational development capabilites with a track record of building high-performing teams. Excellent communication, problem-solving, and decision-making skills in fast-paced environments. Ability to blaance strategic leadership with hands-on operational execution while driving long-term business growth. WORK ENVIRONMENT This is an office-based position that will require some non-standard working hours including early morning or later evening teleconferences to support global prospective and current clients. WHAT WE OFFER Our core values of Respect, Reliability, Collaboration and Excellence shape every aspect of our work and our interactions with all our stakeholders. We seek individuals who are respectful, considerate and honest, value diversity and show integrity in their daily work. Our culture thrives on reliability, ensuring we consistently deliver on our promises and meet the expectations of our stakeholders through operational excellence. We believe in the power of collaboration, fostering an agile environment through teamwork and active listening. Our relentless pursuit of excellence drives us to deliver high-quality products and services, while maintaining a supportive and inclusive atmosphere where every team member is recognised and valued. Join us to be part of a community that is committed to mutual success and high standards. LOCATION This posiion is fully on-site and requires fiver days per week at our Watertown, MA location. Annual base salary range: $175,000 - $200,000 #J-18808-Ljbffr
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