<p>Job Title: Project Engineer IIJob Description</p> <p>The Project Engineer II plays a vital role in ensuring all project components, tasks, and resources meet established quality standards and goals. This position supports departmental operations to ensure compliance with cGMP and OSHA regulations, company Standard Operating Procedures (SOPs), and production goals. Duties and responsibilities are commensurate with the experience level of the Project Engineer and may involve managing small to large cross-functional teams.</p> <p>Responsibilities</p> <ul> <li>Lead and execute assigned engineering projects. </li><li>Develop detailed project schedules and communicate project progress to leadership. </li><li>Collaborate with different departments to ensure timely completion of project tasks. </li><li>Create detailed equipment specifications with Engineering, Maintenance, and Suppliers/Vendors. </li><li>Create detailed Request for Quote (RFQ) documents for large complex projects. </li><li>Generate detailed plant layouts for production lines in AutoCAD and build consensus with Operations. </li><li>Lead and manage equipment installations, including utilities, start-up testing, and commissioning. </li><li>Work with Controls Group to generate detailed strategies for Process Monitoring & Controls. </li><li>Collaborate with Validations Group to plan and execute equipment validations such as IQ/OQ/PQ. </li><li>Create detailed specifications and execute Factory and Site Acceptance Testing (FAT, SAT). </li><li>Generate solid models and detailed drawings for custom parts, spare parts, and tooling. </li><li>Research and maintain knowledge of new manufacturing technologies and provide recommendations to leadership. </li><li>Calculate project costs and compile budgets for planning and justification purposes. </li><li>Support continuous improvement projects if assigned. </li><li>Perform machinery troubleshooting if designated as Subject Matter Expert (SME). </li><li>Complete SOP / Change Control generation & review. </li><li>Coordinate with the Production Department to improve productivity and efficiency. </li><li>Identify gaps in equipment capabilities and recommend alternatives. </li><li>Provide technical support and advice in response to process and equipment problems. </li><li>Evaluate data and provide reports to management on various topics. </li><li>Support general operations concerning AutoCAD and SolidWorks drawings. </li><li>Coordinate with vendors concerning raw material problems and solutions. </li><li>Perform Corrective Action responses to audit or production-related problems. </li><li>Seek performance assessments and participate in training and development programs. </li><li>Promote a culture of accountability, innovation, and customer service. </li></ul> <p>Essential Skills</p> <ul> <li>Bachelor's degree in Mechanical Engineering. </li><li>Minimum of 3+ years of hands-on experience in Project Engineering, Manufacturing Engineering, or a relevant field in an FDA-regulated environment. </li><li>Experience with Plant Expansion, Automation, High-Speed Packaging Lines, or similar projects. </li><li>Proficiency in SolidWorks and ability to create work-cell and line layouts in AutoCAD. </li><li>Ability to compile project timelines in MS Project. </li><li>Basic understanding of FMEA. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Experience in Plant Expansion, Automation, High-Speed Packaging Lines, or similar projects is a plus. </li><li>Documented combination of education and experience. </li><li>Ability to manage small to large cross-functional teams. </li></ul> <p>Work Environment</p> <p>The work environment involves a 50/50 split between an office setting and the production floor.</p> <p>Job Type & Location</p> <p>This is a Permanent position based out of Summerville, SC.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $100000.00 - $115000.00/yr.</p> <p>competitive benefits, DP, ASAP Need</p> <p>Workplace Type</p> <p>This is a fully onsite position in Summerville,SC.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Dec 22, 2025.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>