Director, Facilities & Engineering Jobs

Job Title: Director, Facilities and Engineering

Location: Greenville, NC

This position is responsible for development, implementation and ownership of a comprehensive Process Maintenance (manufacturing and packaging), Reliability Engineering, Automation Engineering, Utility Systems and Facilities Maintenance strategy. This role oversees department leadership including performance management, talent recruitment, strategic planning, capital programs sustainability initiatives and budget.

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

• Develop budget proposals; control charges against approved budget and monitor/report expenditures
• Oversee corporate reporting of capital project health, including budget forecasting; F&E cost savings performance and OEE; sustainability and corporate responsibility projects
• Develop and regularly update the strategic capital improvement plan including site master plan, consisting of facility and utility improvements; production capacity, including facility expansion as needed; support space (office spaces, break rooms, locker rooms, etc.) improvements and expansion as needed
• Organize, manage, develop and implement project plans, construction projects, designs, assembly of equipment, processes and systems to ensure timely project completion, in compliance with regulatory agency requirements, internal company standards and current industry practices
• Maximize the success rate for production operations by instituting programs to minimize mechanical failure and enhance equipment performance
• Recommend solutions and implement appropriate corrective actions for major and complex maintenance issues
• Plan investments in Plant/Personnel/Equipment (PPE) and oversee the departmental budget and headcount, as well as the site’s capital and expense budgets
• Maintain effectiveness of the Quality System components relevant to this position
• Support site’s ability to gain new CDMO business with urgent and accurate capital project scope definition and cost estimates to support strategic partnerships that align with customers’ proper
• Actively influence and participate in the Site Leadership Team and establish cross-functional leadership relationship and presence
• Drive implementation of departmental projects within budgets and timelines and implement new pharmaceutical processing technologies; responsible for setting F&E annual cost savings goals and leading team to exceed the goals
• Manage the training, development and succession planning for direct reports
• Direct responsibility for capital projects, cost control, project schedules, and direct/indirect expenses
• Recruit top talent with every hiring opportunity and motivate/develop members of the department to be key leaders within the organization; build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and the team can excel and continuously improve
• Provide oversight and technical expertise during the development of new strategic manufacturing platforms and products
• Ensure full compliance to OSHA and cGMP regulations at all times and work in concert with cross functional teams to ensure that all departmental projects meet the required standards of both internal and external customers
• Oversee Construction Management in compliance with all applicable safety, regulatory and legal requirements
• Utilize and promote Operational Excellence, Six Sigma & Lean methodologies to all workflows with ability to run Kaizen Events
• Support procurement strategy, equipment expediting/projects and FAT/SAT/IOQ/PQ
• Provide project engineering support on major investment initiatives
• Ensure that appropriate training of all personnel for equipment, process and facility safety and operations is maintained and current

Education or Equivalent Requirements:

• At least 10 years of experience in engineering/engineering management
• At least 15 years of experience in a pharmaceutical/FDA-regulated work environment
• Registered Engineer preferred
• Certified Lean Six Sigma Green Belt or Black Belt preferred
• Demonstrated experience in maintaining regulatory compliance through audits, validation, change management, risk assessments, qualified drawings, corrective action plans, FMEA, and deviation support
• Demonstrated leadership and project management skills
• Bachelor’s degree in Engineering or related discipline

Knowledge/Skills Requirements:

• Exceptional communication skills to effectively interact at all levels of the organization including site presentations to both clients and executive management
• Understanding of relevant legal standards and compliance systems
• Experience successfully leading transformational change
• Strong interpersonal and communications skills
• Experience working to regulatory standards—FDA, Good Engineering Practices (GEP), Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Experience in Central Utilities including, but not limited to: WFI, and Purified Water, Compressed Air, N2, Chilled Water, Steam, Heating Hot Water, Electricity and Sewage
• Proven leadership skills
• Substantial operational engineering experience
• Knowledge of Quality Assurance (QA) and Environmental, Health and Safety (EH&S) standards
• Demonstrated applications of quality improvement methods such as LEAN and Six Sigma
• Experience working on all aspects of capital projects, including budgeting, design, construction, validation, startup and ongoing operations

Physical Requirements:

• Individual may be required to sit for extended periods.
• Individual will be required to work in office areas, machine shop, laboratories, research facilities, warehouses and production areas.
• Specific vision requirements include reading of written documents and frequent use of computer monitor

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job, but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.