Job Overview: We are seeking a highly skilled and experienced Project Lead/Senior Engineering Project Manager to support a brownfield aseptic fill finish manufacturing project.
This role will involve managing concept design, procurement, vendor coordination, installation, and validation of equipment.
Additionally, the candidate should possess strong knowledge of facility build, cleanroom design, and utility systems (including water, steam, and compressed air).
The ideal candidate should be hands-on, operating at a senior engineer level, and be capable of managing schedules, vendors, reporting, and cost analysis.
Key Responsibilities: 1.
Equipment Lifecycle Management: * Oversee the complete lifecycle of fill-finish equipment, from concept to validation.
* Lead the design, purchase, and procurement processes for equipment.
* Manage vendor interactions, ensuring timely and quality deliverables.
* Oversee Factory Acceptance Testing (FAT), installation, and Site Acceptance Testing (SAT).
2.
Facility and Utility System Knowledge: * Lead the design and construction of facility build and cleanroom environments.
* Ensure compliance with industry standards for utilities such as water, steam, and compressed air.
* Collaborate with cross-functional teams to integrate facility requirements with operational needs.
3.
Project Execution and Leadership: * Act at a senior engineer level with a hands-on approach to problem-solving and execution.
* Build and maintain detailed project schedules to ensure on-time delivery.
* Direct vendor engagement and coordinate cross-functional project activities.
4.
Reporting and Cost Analysis: * Provide structured weekly and monthly progress reports.
* Conduct cost analysis to track budgets and ensure project financial alignment.
* Identify risks and mitigation strategies to keep projects on track.
Qualifications & Experience: * Bachelor's or Master's degree in engineering (Mechanical, Chemical, Electrical, or related field).
* Minimum of 10 years of experience in project management within pharmaceutical or biotech manufacturing environments.
* Strong understanding of fill-finish processes, equipment validation, and regulatory compliance.
* Experience in cleanroom design, facility construction, and utility system integration.
* Proven track record of managing complex projects, schedules, and vendor coordination.
* Strong problem-solving, analytical, and decision-making skills.
* Excellent communication skills to effectively engage stakeholders and cross-functional teams.
Preferred Qualifications: * PMP certification or equivalent project management training.
* Experience with GMP-regulated environments.
* Familiarity with automation and process control systems