Sr. Director, Engineering & Maintenance

Responsibilities

• Sets goals for both site and function.
• Provides 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 management.
• Makes sure operational activities are executed effectively across the Engineering functional groups and for the site as a member of the SLT.
• Communicates issues and resolutions to stakeholders in a timely manner.
• Sets and meets customer commitments, including new product introduction timelines.
• Identifies opportunities to improve operational performance.
• Supports strategic business activities such as long range planning, S&OP, capital investment plans, facility master plans, due diligence, and other governance processes.
• Manages operational budget and partners with key stakeholders to plan and manage capital investments.
• Represents Kindeva St. Louis in external interactions with regulatory agencies, customers, government agencies, business partners and service providers.
• Ensures adequate training of employees within the department to perform or exceed job requirements.
• Creates and maintains relationships with other Kindeva engineering teams to develop and promote engineering best practices.

Qualifications

• 15+ 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 functions.
• Direct experience supporting manufacturing facilities and utility systems within an FDA/EMA regulated environment.
• Strong understanding of applicable regulatory requirements (FDA and EMA).
• Audit experience is required.
• Fundamental knowledge of GMP equipment, utility and cleanroom design/installation and quality control laboratory design/installation.
• Strong understanding of industry standards for commissioning, validation, and operation of facilities and utilities for cGMP manufacturing and GxP laboratories.
• Experience with single-use technologies is preferred.
• Experience with a GMP facility startup is preferred.