2630R - Director Of Engineering- Pharma Plant

Our client – a growing company, needs a Director of Pharmaceutical Plant Engineering to support expansion to manufacture new pharma products. Excellent salary up to $220K base+ Annual Bonus + Relocation + Full Benefit Package. Job Posting # 2630R Job Title: Director of Engineering- Pharma PlantLocation: Lawrence, KS Compensation: Base of $180K - $220K per year + Annual Bonus Target of 30%Relocation: YES - Client offers relocation assistance if needed.Benefits: Full package for medical, dental insurance, 401KOur client is a privately held company in business for 40 years with 2 sites in CA + KS with around 300 peopleGroup Info: Be part of the pharmaceutical contract manufacturing and medical device site with around 100+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing.The new operation expansion is for Pharma Fill Finish Seal – FFS of Sterile Aseptic liquids.This Engineering group has around 6 Technical people for various functions like Manufacturing, Project Management, Systems, Automation etc.Note 1: This person will not manage the Maintenance department since it is part of the operations group. The Facilities & Maintenance Manager + this Director of Engineering will report to the site General ManagerJob Summary:The Director will oversee plant engineering and ensure that proper engineering procedures are followed.Job Description:

• Oversees progress and timeliness of projects.
• Reviews project reports to ensure projects are on schedule and within budget.
• Provides leadership for employees through effective communication, coaching, training, and development.
• Provides leadership for problem resolution to facilitate fast improvements and improved working relationships.
• Develops and implements a culture of continuous improvement through self-directed work teams.
• Leads design engineering related to new product development and product & systems enhancements.
• Develops and oversees machine and process validation programs, ensuring validation timelines are met.
• Work with production to be aware of production schedule and needs, ensuring manufacturing engineering is working as a team with production to achieve goals.
• Prepare and manage capital projects including identifying scope, cost, milestones, etc.
• Establishes, prepares, implements, revises, and maintains policies and procedures related to engineering and facilities.
• Oversees scope development, estimating and schedule commitments as part of building capex project proposals and administers and oversees Master site planning efforts at sites as required
• Drives site projects and project teams as needed, works with sites to problem solve and clear roadblocks during execution, and coordinates governance metrics for sites in the network
• Support operating sites in the following areas: Capex planning, Technical reviews on projects
• Review, analysis and recommendations on new technologies and/or service providers
• Operational review on challenging site problems (i.e. Contaminations, equipment robustness etc.)

Supervisory Responsibilities:

• Plans and coordinates the work of Engineering staff.
• Oversees engineering staff and ensures that they meet goals and objectives.
• Recruits additional engineering staff as needed.
• Conducts performance evaluations that are timely and constructive.
• Provides training and mentoring as needed.

Candidate Must Have:

• Bachelor’s degree in Engineering or related field
• Min. 15 years of Engineering experience.
• Min. 5 years of Engineering Management/ Director experience in the Pharma Industry
• Excellent people, communication and management skills to create a team environment
• Good leadership skills to motivate plant personnel and gain their respect
• Solid knowledge base and experience in engineering/construction project controls and project execution and ability/experience functioning globally within a diverse team
• Ability to produce and present clear, concise, and professionally written communications and presentations.

Candidate Nice to Have:

• PE license or Master’s degree in Engineering or an MBA
• Knowledge of Sterile Aseptic Filling Operations
• Startup or Small company experience working in a dynamic and hands-on role.
• Six Sigma, Lean Manufacturing, continuous improvement, etc.
• Contract Manufacturing experience working closely with customers and clients
• Hands-on experience with Capital Project Management
• Experience with remediation from FDA warning letter situation
• Ability to work in fast paced medium company dynamic environment

Keywords: BioPharma, Pharma, Engineering, FDA, warning letter, 483, CMO, Sterile Aseptic, filling, FFS, Management, six sigma, Lean, CDMO, Manufacturing, Plant, Capital Project Management, PE.