Strategic Head of Facilities & Engineering for Pharma GMP

Kindeva Drug Delivery; St. Louis (MO); On-site; USD 180,000 - 240,000; Full time

Job summary

Kindeva Drug Delivery in St. Louis is seeking a Sr. Director of Facilities and Engineering to lead engineers, automation, metrology and validation staff across three sites.

You will drive maintenance, capital planning and regulatory compliance for aseptic filling and packaging operations. Reporting to the VP & General Manager, you will align site goals with business objectives, manage budgets, and collaborate with regulatory, quality and manufacturing teams to deliver robust facilities and

Qualifications

• 15+ years of related experience in the Pharmaceutical or related industry including experience in engineering, operations and project management.
• 10+ years in a functional leadership position within one or more areas including Process Engineering, Facilities/Engineering, Maintenance, Automation, Validation or related functions.
• Experience in building own team and project teams and developing teams’ capabilities to deliver results.
• 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

Responsibilities

• As a member of the Site Leadership Team, 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.
• Monitors tactical execution of operational activities across the Engineering groups; communicates issues/resolutions.
• Sets and meets customer commitments including new product introduction timelines.
• Identifies opportunities to improve robustness, reliability, and operational performance.
• Provides Engineering expertise at site and across sites; supports long range planning, capital investment, and governance processes.
• Manages operational budget and partners with stakeholders to plan capex.
• Represents Kindeva St. Louis with regulators, customers, and service providers.

Skills

Pharma experience

Leadership

Team building

Regulatory experience

Audit experience

GMP knowledge

Commissioning & validation

Single-use tech

GMP startup

Job description

Kindeva Drug Delivery in St. Louis is seeking a Sr. Director of Facilities and Engineering to lead engineers, automation, metrology and validation staff across three sites.

You will drive maintenance, capital planning and regulatory compliance for aseptic filling and packaging operations. Reporting to the VP & General Manager, you will align site goals with business objectives, manage budgets, and collaborate with regulatory, quality and manufacturing teams to deliver robust facilities and