Job Overview:

In this role the Senior Director, Facilities & Engineering will be responsible for the Engineering, Maintenance, and Site Services for the Pharmaceutics International Inc., (‘Pii’), Holly Mount, MD Facilities, which includes the four buildings owned or leased by Pii (collectively ‘the Site’).

The Senior Director, Facilities & Engineering provides life cycle asset and facilities management leadership for the Site by implementing strategies that assure sustainable, reliable and repeatable performance for compliant, effective and efficient infrastructure. Under the general supervision of the Site General Manager, the incumbent is responsible for all activities related to Site Engineering, Capital, EH&S and Facilities Reliability Operations. The span of control of this position includes all plant infrastructure, facilities reliability, automation, and utilities programs; as well as all aspects of engineering with a special focus on GMP Manufacturing equipment uptime, including the routine reporting of equipment and system status, and the reliable supply and compliance of Critical Utilities (HVAC, Purified Water, Clean Compressed Air, etc.) as well as utility (plant water, electrical service and wastewater) and indirect utilities (chilled water, cooling, tower, chillers, compressed air systems, etc.) In addition, the incumbent is responsible for project scoping, capital and department expense budgeting and monthly forecasting, governance, day-to-day management of site capital projects and escalation of critical issues related to safety and/or operations impacts. The Site Engineering Manager is also accountable for commissioning and qualification activities associated with capital projects.

The Senior Director, Facilities & Engineering will maintain a learning organization, establish training curriculums and enforce training requirements and timelines, develop engineering department leaders and promote collaboration with internal key stakeholders (including manufacturing, technology, supply chain, finance, etc.), and establish and maintain routine governance processes to maintain proactive lines of communications.

The Senior Director, Facilities & Engineering is a member of the Site Leadership Team (‘SLT’) and is expected to routinely report out on the state of good repair both to the SLT and as required to support Quality Assurance Programs (Quality Managements Reviews, Deviation, CAPA and Continuous Improvement, etc.).

Responsibilities:

• Maintain a safe working environment. Monitor and report on department (and Site?) Environmental, Health and Safety Performance. Support and comply with required safety training and required safety system testing for equipment and facilities..

• Support the design, construction, and operation of all four (4) facilities such as solid, soft gel, Aseptic manufacturing, and GMP labels.

• Ensure the Pii facilities meets the appropriate cGMP standard or identify where the gaps are in the Pii Facilities GMP compliance position and make recommendations to the leadership team for the remediation of the gap. Supervise, and monitor the environmental conditions of the cGMP areas, and ensure all parameters meet the cGMP requirements.

• Manage and maintain the annual site capital expenditure (cap EX). Develop an annual Facilities and Engineering department operating expense budget and routinely forecast performance to the budget. Proactively collaborate with Finance regarding capital or operating budget status.

• Responsible for ensuring that the facility and equipment are kept up-to-date and in a good state of repair. Maintain an asset management plan and a Computerized Maintenance Management System.

• Develop and implement the automation vision and strategy for the organization

• Develop cost effective and accelerated initiatives to meet high mix/low volume applications

• Drive technical automation teams in the development of innovative automation equipment and solution design(s)

• Optimize automation equipment, improve production efficiency, including where necessary reforming the existing automation technology.

• Provide engineering and reliability support for all agency audits like FDA, MHRA, and EMA. Maintain all facility drawings of record, facility design strategies, and on-going controlled environment data.

• Reviewing SOP, URS, DQ, TQ, IQ, OQ, PQ’s and Change Controls for all facility engineering equipment and controlled and non-controlled Site environments.

• Facilitate and lead facilities engineering capital projects related to new and upgraded equipment, processes, facilities, IT site operational initiative, site compliance, quality and safety initiatives.

• Support and Lead all facility/equipment/systems related Change Controls, Quality Events (QE), Deviations, Corrective and Preventative Action (CAPA’s), Continuous Improvements and Effectiveness Checks.

• Implement and enforce engineering and reliability procurement processes and standards for securing services, equipment, and materials.

• Reviews proposals, negotiates prices, selects, and recommends suppliers, analyze cost trends, follows up on orders placed, verifies deliveries, approves vendor payments and maintains necessary records.

• Communicate cross-functionality 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 the necessary training.

• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

• Maryland first-grade stationary engineer license

• 8 to 10 years of work experience in the pharmaceutical industry

• Extensive technical acumen in the field of automation including automation design and implementation

• Demonstrated track record leading multiple successful automation implementations

• Building and equipment maintenance work experience

• Knowledgeable in AutoCAD and building management system (BMS)

• 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 ability to acquire knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

• Demonstrate ability to acquire 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, Good Engineering Practice (‘GEP’), Lean and Six-sigma, 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.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.

• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

• Ability to lift up to 40 pounds on occasion.

• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).