Senior Director Engineering

2 weeks ago

Maryland Heights, United States Curium Live Forward Full time

Summary of Position

The Senior Director North America Engineering Services serves a pivotal role in overseeing critical aspects of engineering operations, ensuring safety, compliance, and efficiency in a radioactive pharmaceutical facility. Responsibilities will encompass New Product Initiatives, Controls Engineering, and CapEx Program and Project Management. The role will lead a team of skilled managers and professionals and collaborate closely with cross-functional departments to drive excellence in engineering services, adhering to regulatory standards and guidance.

Essential Functions

New Product Initiatives:

Support cross-functional project teams with SME guidance in process, operations, and quality compliance for process evaluation, design, and implementation. Partner with Site Leadership for efficient project implementation without affecting current operations. Provide strategic guidance for BD&L, M&A, PMO, and CMO activities. Lead engineers and scientists to collaborate with Project Managers for swift project progression from scoping to implementation. Offer Operations and Aseptic Manufacturing expertise for evaluating and designing new processes and equipment. Ensure cGMP and Validation practices for evaluating new products within manufacturing equipment and clean rooms to maintain quality standards. Conduct technical evaluations of new products for compatibility with current processes and robust design. Provide estimates for operations, quality, and validation activities to set accurate cost and schedule targets. Maintain forecast estimates for project costs and track tasks to meet project milestones. Manage product launch activities and coordinate with R&D, Manufacturing, Quality, Engineering, and Maintenance for SOPs, Batch Records, and Training Documents. Define requirements and generate project validation plans. Guide project quality assurance and validation activities in partnership with QA functions. Generate and maintain project quality risk assessments, including FMEA. Support the preparation of documentation for regulatory filings.

Controls Engineering:

Lead the Controls Engineering team in designing, implementing, and validating control systems that comply with Process Validation regulations. Develop and manage automation standards. Maintain a Change Control system to manage control system changes per regulations. Collaborate with Validation and Quality Assurance teams for risk assessments and validation activities. Implement advanced process control strategies to optimize production processes and reduce variability.

CapEx Project Management:

Develop a Capital Expenditure Plan aligned with strategic objectives and regulatory requirements. Define KPIs for capital project execution and use continuous improvement principles to manage and improve project performance to quality, schedule, and budget expectations. Prepare detailed project proposals and justifications with cost-benefit analyses, ensuring compliance with regulations. Utilize a robust Project Management system for project execution. Lead cross-functional teams to ensure projects meet scope, schedule, and budget targets. Conduct comprehensive risk assessments for capital projects, including guidance on Risk-Based Approach to Computerized Systems in GxP Regulated Environments. Develop and manage the site controlled drawing program in accordance with regulatory guidance.

General:

The Senior Director of Engineering Services ensures the radioactive pharmaceutical facility meets and exceeds regulatory expectations from FDA, Eudralex, TGA, HC. Leadership, attention to detail, and commitment to safety and compliance are critical for delivering high-quality pharmaceuticals while adhering to the highest ethical and regulatory standards. Ensure all programs maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).

Requirements

Bachelor of Science degree in Engineering required, Master of Science degree preferred.  Minimum of twenty years of relevant experience in Mechanical, Chemical, Electrical, or related field. Ten or more years in a leadership role required including multi-level leadership of professional teams. Ten or more years of project management experience. Experience managing capital projects in excess of $K, including estimate development, capital justification and approval, schedule development/management, and execution.  Ten or more years of combined engineering and operations experience in the pharmaceutical industry. Subject Matter Expert knowledge of aseptic technique, regulatory requirements, and validation activities needed for manufacturing parenteral products Technical understanding of the pharmaceutical development process from concept to launch  Experience with radiation safety programs and radioactive manufacturing processes Experience interfacing and presenting to with executive leadership.  Excellent written and oral communication skills, with proven ability to scale communication style from technical to executive audiences. Lean and/or Six Sigma training/certification preferred. Experience ensuring cGMP compliance. Proven ability to develop and implement vision and cultural changes. Fiscal / budgetary responsibility. Experienced with formal Root Cause identification and correction. Proven Leadership ability and effective in conflict resolution. Must be self-managed, wholly responsible for department, committed to meeting deliverables and timelines with limited direction from supervisor. Ability and willingness to work near and around radioactive products.

Working Conditions

Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.  Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.

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