Description:

• Provide technical leadership and guidance to engineering and project teams in the development of solutions.• Collaborate with executive leadership to develop and meet organizational goals while supplying expertise and guidance on projects, operations, and systems.• Draft and execute change controls, ECR’s, and SOPs in accordance with operating in an FDA regulated facility. • Proficient with reviewing and understanding construction drawings including PFDs, P&IDs, architectural, mechanical, and electrical drawings.• Implement the strategic direction of PolyPeptide Group engineering and development initiatives.• Serve as the Engineering Subject Matter Expert (SME) during the planning, conceptual design, basic design, and detailed design phases of a project.• Support Failure Modes and Effects Analysis (FMEAs) and HAZOPs on equipment and utility systems to identify and address high-risk failure modes to ensure adequate maintenance and reliability during operate and maintain phase.• Resolving scope changes with engineering, site quality (when applicable) and construction.• Working with procurement on equipment purchases as well as contractor agreements.• Project execution meetings, forecasting including input from contractors, and status execution updates.• Support Validation execution in an Engineering Subject Matter Expert (SME) role, including resolution of deviations/non-conformities. • Coordinates Commissioning and Qualification of Facilities, Utilities and Equipment.• Process Improvements• Perform other duties as assigned.

Skills:

project engineering, Qualifications, Protocols, GMP, design control, design, PFMEA, capital project, fda, facilities maintenance/management, CMMS, lean manufacturing

Top Skills Details:

project engineering,Qualifications,Protocols,GMP,design control,design,PFMEA,capital project,fda

Additional Skills & Qualifications:

• Bachelor’s degree in chemical or mechanical Engineering.• 3-5 years of relevant experience in a GMP environment.• Proven experience in project management and team leadership.• Strong knowledge of GMP regulations and compliance standards.• Excellent communication and people skills.• Meticulous with a focus on quality and continuous improvement.• Ability to adapt to a fast-paced and dynamic work environment.

Experience Level:

Intermediate Level

About Actalent

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.