Director Engineering

Purpose and Scope

The Director of Engineering oversees the company's Project, Equipment, Automation, and Packaging Engineering functions. These groups focus on full life cycle support in the following areas: Long range planning/strategy, infrastructure, Facilities, Utilities, Processing, Manufacturing equipment, R&D and Manufacturing support, Qualification/Re-qualifications, Device/Packaging/Artwork/Specification life cycle management, OpEx/Continuous Improvement, etc.

Essential Duties & Responsibilities

• Provide oversight and direction to the engineering team in execution of improvement projects including, but not limited to: construction, equipment, product components, and automation projects that are capital and non-capital purchases.
• Supervise activities to ensure operational readiness of all Tolmar facilities and process/packaging equipment within budget and in compliance with established regulations.
• Lead teams to properly select, purchase, and qualify equipment for processing, controlling, packaging, and transporting raw ingredients, formulations, intermediates, work in process, and/or finished products.
• Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate.
• Evaluate facilities' operations, process/packaging equipment, and packaging components to optimize productivity and quality.
• Evaluate/improve internal processes, procedures, systems streamlining execution and the ability to be nimble.
• Collaborate closely with the maintenance organization improving equipment and infrastructure reliability.
• Prepare/establish budget for department; monitor adherence to budget and authorize expenditures.
• Contract with outside service providers when required to offset staff needs and to provide expertise in certain areas.
• Provide recommendations to executive management to resolve issues and drive operational improvement.
• Develop and maintain successful working relationships with both internal and external clients.
• Ensure the engineering department's compliance to established company safety policies and procedures.
• Represent the engineering department at management and other company meetings, as required.
• Support the monitoring and automation of all critical systems and equipment (ex. DI, WFI, and USP).
• Support the monitoring and maintenance of the operation and data associated with all building and utility management systems (Examples include EBI, JCI, etc).
• Represent the Engineering group/processes/systems/equipment during internal and external audits including regulatory agency visits.
• Provide the Quality department required information during audits by regulatory agencies or partners.
• Collaborate with Product Development, Manufacturing and other organizations to provide engineering support to meet the specific design requirements necessary for the successful introduction of new products into the manufacturing facility.
• Lead multidisciplinary teams within the company to solve infrastructure/equipment/product /controls/process issues.
• Develop systems/processes for engineering reporting (KPIs) and ensure accurate and timely reporting of critical information.
• Provide technical assistance to the maintenance organization as necessary.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Proficient knowledge of current Good Manufacturing Practices (cGMP), ISO, EU, and JP standards for aseptic processing, clean rooms, and semi-solids manufacturing.
• Strong working knowledge of pharmaceutical equipment, processes, and automation and control systems.
• Possess an understanding of FDA validation guidelines and industry best practice for this field and be able to implement standards.
• Planning skills including resource allocation and timeline development.
• Project management skills, project budgeting and contract administration, and an ability to multi-task and prioritize frequently changing needs.
• Strong knowledge of principles and practices of facility planning, construction, manufacturing/equipment, R&D support, packaging components, and validation.
• Excellent interpersonal, communication, problem-solving and organizational skills.
• Proven skill in effective management and leadership.
• Ability to analyze complex development problems and implement effective solutions.
• Ability to manage multiple projects.
• Ability to create and manage departmental budget.
• Working knowledge of operational excellence/continuous improvements, equipment reliability, LCM (life cycle management), site master planning Programs.

Core Values

• The Director of Engineering is expected to operate within the framework of Tolmar's Core Values:




• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's Degree in Engineering or related discipline required.

• Ten or more years of experience in Project/Facilities, Equipment, Packaging, Validation engineering management role of increasing responsibility, preferably in the pharmaceutical manufacturing environment.

Working Conditions

• Working conditions are typical for a pharmaceutical manufacturing environment.
• Weekend or evening hours as business needs require.

Compensation and Benefits

• Pay: $205,000 to $220,000 depending on experience
• Bonus eligible
• Benefits summary: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.