Senior Project Engineer

• Responsible for providing technical leadership and engineering support for Bulk Drug Substance (BDS), Drug Product (DP), and Process Science (PS) systems within a GMP manufacturing environment.
• The role focuses on equipment troubleshooting, project execution, process optimization, compliance, and continuous improvement initiatives across biopharmaceutical manufacturing operations.

Requirement/Must Have:

• Strong expertise in GMP manufacturing environments.
• Hands-on experience with process systems and manufacturing equipment.
• Experience with bioreactors, centrifuges, chromatography skids, columns, CIP/SIP systems, and filling and packaging equipment.
• Strong troubleshooting and root cause investigation skills.
• Experience leading CAPEX, OPEX, or continuous improvement projects.
• Ability to manage change controls, deviations, CAPA, and risk assessments.
• Strong project leadership and contractor management experience.
• Knowledge of FDA, OSHA, and GMP compliance requirements.
• Excellent communication and cross-functional collaboration skills.

Experience:

• Minimum 5 years of hands-on experience with process systems and equipment.
• Minimum 4 years of experience in a GMP manufacturing environment.
• Experience managing startup, commissioning, qualification, and validation activities.
• Experience leading engineering projects from feasibility through handover.
• Experience supporting manufacturing, quality, supply chain, and engineering operations.

Responsibilities:

• Serve as the engineering technical lead for BDS, DP, and Process Science systems.
• Support troubleshooting of process and equipment-related issues.
• Lead and participate in CAPEX, OPEX, and continuous improvement projects.
• Manage medium-sized equipment-related engineering projects.
• Perform system owner responsibilities for process equipment when required.
• Conduct technical analysis related to equipment utilization, process optimization, and sustainable design.
• Lead startup, commissioning, qualification, and validation activities.
• Review and approve protocols, reports, SOPs, and technical documentation.
• Lead project teams and oversee contractor activities.
• Support risk assessments, change controls, deviations, and CAPA investigations.
• Ensure manufacturing systems comply with quality, compliance, and EHS standards.
• Drive optimization initiatives and process improvements.
• Participate in global engineering reviews and technical standard improvements.
• Collaborate with cross-functional teams including Manufacturing, Quality, SCM, Finance, IT, and external partners.
• Support regulatory inspections and compliance activities.

Should Have:

• Experience in biopharmaceutical or pharmaceutical manufacturing environments.
• Strong analytical and problem-solving skills.
• Ability to manage changing priorities in fast-paced environments.
• Experience working with contractors, auditors, and external stakeholders.
• Domestic or international project support experience preferred.

Skills:

• GMP compliance and regulatory knowledge.
• Process equipment troubleshooting.
• Risk assessment and root cause analysis.
• CAPA, deviation, and change control management.
• Startup, commissioning, and qualification activities.
• Project leadership and contractor oversight.
• Process optimization and continuous improvement.
• Technical documentation and SOP development.
• Cross-functional collaboration and communication.

Qualification And Education:

• Bachelor s degree in Engineering with 5 10 years of related experience, or
• Master s degree in Engineering with 5+ years of related experience, or
• Professional Engineer (P.E.) License.