Head of Engineering and Facilities

1/24/24

Towson, MD

2225

FullTimeRegular

#2225 Head of Engineering and Facilities

Our client is a well established pharmaceutical contract manufacturer and developer of finished pharmaceutical products. They are currently experiencing a significant amount of growth in 2024 and beyond and have an opening for an Engineering Leader who can help improve current operations and who can help to oversee future site expansions and upgrades.

Responsibilities Include:

  • Manage the P&L, ensuring budget adherence, maximizing profitability.
  • Champion of quality systems, ensuring overall adherence to quality standards.
  • Change Management: ability to guide the organization through the necessary changes needed to manage changes to the strategic business plan and improve results in a win/win management style.
  • Evaluate/guide pipeline development and the eventual scale up of approved products, ensuring adequate installed capacity and capability exists to satisfy product demand.
  • Overall responsibility for the safety and adherence to all environmental site requirements.
  • Interacts with and reports progress on a regular basis to the Board of Directors.
  • Develops strategic business plans and the development and delivery of the annual work plan.
  • Perform other duties as assigned.

Qualifications Include:

  • Design, construction, and operation of all four (4) facilities such as solid, soft gel, Aseptic manufacturing and GMP labels.
  • Ensure the 450k square feet of facility at the company meets the appropriate cGMP standard, supervise, monitor the environmental conditions of the cGMP areas, and ensure all parameters meet the cGMP requirements.
  • Partner with F&E leaders to maintain the annual site capital expenditure (cap EX) and operating expense of the Facilities and Engineering department.
  • Manage the facility engineering department, facility projects and management teams.
  • Responsible for ensuring that the facility and equipment are kept up-to-date and in good working order.
  • Provide engineering support for all agency audits like FDA, MHRA and EMA
  • Reviewing SOP, DQ, TQ, OQ, PQ's and Change Controls for all facility engineering equipment and area.
  • Design, modify, operate and maintenance of manufacturing equipment, facilities, and processes to meet cGMP standard.
  • Facilitate and lead facilities engineering projects related to new and upgraded equipment, processes, facilities, site operational initiative, site compliance and quality initiatives analyzing.
  • Provide coordination and support for all facility, equipment/systems related change control, Quality Events (QE) deviations, Corrective and Preventative Action (CAPA’s), and Capital Projects
  • Reviews proposals, negotiates prices, selects, and recommends suppliers, analyses, trends, follows up on orders placed, verifies deliveries, and maintains necessary records.
  • Communicate cross-functionality and with customers, vendors, suppliers, contractors, and management on all department needs and project related activities.
  • Manage, track, and ensure that all GMP work orders are performed as required.
  • Review all the clean room parameters such as pressure, temperature, and humidity. Maintain and regulate/control the HVAC and SCADA
  • Hire required personnel for the department and provide necessary training.
  • Perform other duties as assigned.

Requirments:

  • High School Diploma, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
  • Associate or bachelor’s degree preferred.
  • Maryland first grade stationary engineer license
  • 8 to 10 years work experience in the pharmaceutical industry
  • Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
  • Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
  • Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
  • Must be able to comprehend and follow all applicable SOPs.
  • Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
  • Demonstrate solid understanding the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
  • Good understanding of cGMPs, industry, and regulatory standards and guidelines.
  • Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
  • Demonstrate the ability to portray the appropriate level of integrity and professionalism.
  • Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
  • Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
  • Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
  • Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
  • Results-oriented and efficient.
  • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
  • Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
  • Demonstrate the ability to work well in a cross-functional team environment.
  • Must communicate fluently in English and have legible handwriting.

Benefits:

  • Competitive salary and annual target bonus
  • Competitive medical, dental, vision and health benefits.
  • Competitive paid time off policy
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