Senior Director, Engineering

Summary of Major Responsibilities

The Senior Director, Engineering, will be responsible for organizational leadership of all aspects of operations engineering including FDA regulated automated bulk reagent manufacturing and dispensing and clinical laboratory automation related to sample and material handling including waste management  in a CAP/CLIA regulated environment. This position will be responsible for developing and managing a team of professionals that provide world class service in a fast-paced demanding atmosphere. Managing technology, vendors, consultants and in-house engineers to provide daily technical support and drive safety, quality, reliability, and performance across multiple sites is critical to success. This role requires strong collaboration with key stakeholders, strategic planning, and partnering with functional departments such as production, research and development, IT, project management, service and support and others as needed to plan and execute automation improvements.

Essential Duties and Responsibilities

  • Plans, directs, and manages operations engineering activities to deliver approved projects for capacity expansion and scale up activities, as well as continuous improvement and cost reduction projects from inception through transfer.
  • Measures automation equipment effectiveness to proactively identify risks and improvement opportunities.
  • Defines metrics and reporting around automated processes to drive efficiencies and reliability.
  • Oversees the commissioning of new automated systems developing protocols and requirements.
  • Oversees the maintenance of automated systems ensuring the units maintain qualified and validated states.
  • Creates multiple-year automation plans to support expansion, improvement, and future product pipeline efforts including budget development and approval.
  • Creates engineering standards and collaborates with stakeholders to develop project approval processes, project execution deliverables, and engineering support responsibilities.
  • Ensures engineering activities are compliant with all related SOPs and QMS requirements.
  • Manages software solutions for PLC, SCADA, and data historian systems.
  • Prepares required reports for management review and approval.
  • Creates and manages annual Engineering budget, including capital expenditures and staffing and oversees cost center working closely with leadership and finance.
  • Researches and evaluates potential new equipment, processes, procedures, technologies and automation that may improve performance and/or cost.
  • Leads, motivates and develops a professional engineering team, setting clear priorities and allocating resources in order to meet and exceed functional objectives. Coaches and mentors employees in other functional areas.
  • Assists in the development of short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
  • Actively influences and participates in the site leadership team and establishes effective cross-functional leadership relationships and presence.

Qualifications

Mandatory Skills

  • Excellent oral and written communication skills required.
  • Strong vision and history of implementing a high level of service.
  • Excellent organizational, project management, and problem-solving skills required.
  • Ability to work independently with minimal direct supervision required.
  • Experience interfacing with various regulatory agencies and auditors required.
  • Adaptable, flexible, open to change and able to work in ambiguous situations responding to new information and unexpected circumstances in a timely manner.
  • Demonstrated attention to detail required.
  • Ability to establish agreement and consensus with stakeholders required.
  • Ability to effectively engage employees required.
  • Strong interpersonal and teamwork skills including the ability to easily convey concepts and priorities to peers, customers, leadership, and cross-functional teams required.
  • Strong people leadership skills, and prior success in leading by influence.
  • Executes and leads the team with a sense of urgency.
  • Experience in biotech manufacturing environment preferred, particularly with a GMP and/or ISO13485 environment.
  • Ability to course correct when issues arise with strong tactical and clear execution plans.
  • Leads initiatives to improve systems, process, procedures to drive quality.
  • Ability to deliver financial results for areas of accountability.
  • Ability to be flexible, approachable and inspire trust.
  • Energetic, resourceful and hands-on individual with a strong service orientation and bias for action; understands impact of decisions or strategies.

Education and Experience

  • Bachelor or master’s degree in mechanical or electrical engineering or equivalent from an accredited university.
  • 15+ years of industry experience.
  • 10+ years of related experience in a regulated environment (bio/pharma preferred).
  • 10+ years of direct leadership experience.
  • Experience with OSHA, and FDA (preferred) regulations required.
  • Experience interfacing with various regulatory agencies and auditors required.

Additional Desired Characteristics

  • Master’s degree.
  • Experience with CAP/CLIA regulations desired.
  • Strong knowledge of Lean Manufacturing, 5S and Kaizen methodologies.

Physical Requirements

  • Ability to use and wear safety protective gear/equipment (e.g. safety glasses, lab coat, gloves, respirator, etc.) and follow safety guidelines.
  • Ability to use computers daily in an interactive manner for extended periods of time and up to 8 hours per day.
  • Ability to sit for an extended period of time.
  • Ability to stand for extended periods of time and up to 6 hours at a time.
  • Ability to travel (by land and air), on occasion.
  • Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.
  • Constant walking or motion to coordinate work and interact with co-workers.
  • Ability to lift and move up to 40 pounds on an occasional basis.
  • Specific vision abilities required by this job include close vision, color vision, depth.
  • Ability to work with hazardous or flammable materials (e.g. chemicals, radioactivity, electrical equipment) so as not to endanger oneself or others.

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EEO Disclosure

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.


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