Develop project plans, including scope, requirements, resources, schedules, cost estimates, risk mitigation strategies, and communication plans.
Monitor project progress, coordinate critical-path activities, evaluate operational impacts, and provide project status reporting to stakeholders.
Engineering Design, Construction, and Vendor Management
Define project specifications, equipment requirements, and technical solutions while preparing scopes of work, feasibility studies, and engineering documentation.
Manage the full construction lifecycle, including RFP development, bid evaluations, contractor and consultant selection, design reviews, approvals, and commissioning activities.
Ensure designs, plans, and facility modifications meet operational needs, building standards, and code requirements while applying value engineering principles.
Validation, Quality, & Regulatory Compliance
Lead validation activities for equipment, facilities, and utilities, including protocol development, execution, issue resolution, commissioning, and IQ/OQ/PQ documentation.
Develop and maintain SOPs and quality documentation while supporting CAPAs, deviations, change controls, and continuous compliance initiatives.
Ensure adherence to cGMP requirements, safety standards, customer expectations, and applicable regulatory requirements.
Financial Management, Leadership & Stakeholder Collaboration
Manage project budgets, CAPEX requests, expenditures, contracts, cash flow, and cost-benefit analyses to achieve financial targets.
Partner with operations, quality, engineering, procurement, and leadership teams to gather requirements, prioritize project needs, and support strategic business goals.
Provide day-to-day project leadership, facilitate stakeholder communication, and drive successful project execution in a fast-paced manufacturing environment.
Qualifications
Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Electrical, or related engineering discipline) required.
Minimum 4 years of engineering experience in project planning, project management, capital projects, construction, facilities, utilities, or manufacturing environments.
Previous experience in pharmaceutical, biotechnology, life sciences, sterile manufacturing, or other regulated industries is required for consideration.
Experience in a pharmaceutical cGMP manufacturing, packaging, OSD, or sterile setting required.
Knowledge, Skills, and Abilities
Experience leading cross-functional projects from concept through implementation, including scope development, budgeting, scheduling, contractor management, and project execution.
Demonstrated experience managing capital improvement, facility, equipment, utility, or construction projects within regulated manufacturing environments preferred.
Experience supporting validation activities, including commissioning, IQ/OQ/PQ execution, and validation documentation preferred.
Experience preparing project cost estimates, CAPEX justifications, bid evaluations, and financial tracking for engineering projects.
Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) required; experience with project management and scheduling tools preferred.
Strong technical, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
Excellent communication, presentation, and stakeholder management skills with the ability to collaborate effectively across all levels of the organization.
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
