Job Description We are seeking an experienced Mechanical Project Engineer to support a Large Pharmaceutical Capital project. This role will focus on Engineering design, procurement, startup, vendor management, commissioning, and qualification. The ideal candidate will have experience with mechanical systems, including clean and dirty utilities as well as autoclaves and parts washers. The Mechanical Project Engineer will be responsible for reviewing engineering submittals and drawings, reviewing and responding to RFIs, supporting infield execution and startup of mechanical systems, and Engineering closeout, including following resolution of punch list items and final review and approval of Engineering Turnover Packages (ETOPs) to ensure compliance with project requirements and industry standards. The candidate should also have strong organizational skills, and excellent communication abilities to collaborate effectively with cross-functional teams and vendors. Engineering Design & Execution: - Oversee Mechanical Engineering, ensuring GMP compliance. - Provide technical expertise for mechanical systems. - Review and approve engineering submittals. - Review drawings and specifications, resolving discrepancies. - Respond to RFIs and support design reviews and risk assessments. Vendor & Stakeholder Management: - Manage relationships with vendors, contractors, and suppliers. - Validate vendor submittals and collaborate with cross-functional teams. - Coordinate Site Acceptance Testing (SAT). Project Coordination & Instrument Implementation: - Oversee planning and execution of mechanical system implementation. - Maintain project schedules and ensure timely delivery. - Collaborate with internal stakeholders for smooth execution. Startup, Commissioning & Qualification: - Support startup and commissioning plans. - Support IQ, OQ, and PQ activities. - Ensure adherence to cGMP, FDA, and company standards. - Facilitate punch list generation and resolution. Project Support & Problem-Solving: - Provide technical troubleshooting and resolution. - Identify and mitigate risks. - Ensure proper documentation of engineering activities. Compliance, Documentation & Reporting: - Ensure installations and qualifications meet regulatory standards. - Maintain detailed project records. - Assist in SOP development and provide status updates to leadership. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 7 years of experience in mechanical engineering pharma or biotech industry background knowledge of clean and dirty utilities, autoclaves, and parts washers in a GMP environment exp with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities capital project experience null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.