Sr. Director, Facilities and Engineering

Kindeva Drug Delivery•Maryland Heights, MO

33d•Onsite

About The Position

Reporting to the Vice President & General Manager, the Sr. Director of Facilities and Engineering is responsible for a staff of engineers, facility 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 products. This role assures strategic alignment to site vision, strategic, and operational plans to assure achievement of site and business objectives. As part of the site / extended 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 programs. The 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 compliant.

Requirements

Bachelor’s degree
15+ years of related experience in the Pharmaceutical or related industry including experience in engineering, operations, program 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
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 experienced 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
Understands and applies a broad range of financial management principles to ensure decisions are fiscally responsible.

Nice To Haves

Bachelor’s degree in engineering
Experience working in an external manufacturing environment as supplier or client
Experience with single-use technologies
Experience with a GMP facility startup

Responsibilities

As a member of the Site Leadership Team (SLT), 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.
Monitors 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 manner.
Sets and meets customer commitments including new product introduction timelines
Identifies opportunities to improve robustness, reliability, and other aspects of operational performance
Provides 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 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 (skills-based, cGMP and Safety) of employees within department to perform or exceed job requirements.
Creates and maintains relationships with other Kindeva engineering teams to develop and promote engineering best practices