Description: • Responsible for the design, modifications, validations to ensure GMP compliant, procurement, vendor coordination, project management, change management ownership, increasing yields / processing efficiencies • Lead and participate in cross-functional projects with limited direction • Collaborate with Manufacturing, QA and Technical Operations to ensure the successful manufacturing of biologic processes • Identify areas for improvement or optimization, lead implementation of best practices, and/or present data to applicable departments on the outcome of investigations or optimization initiatives • Contribute to and/or lead technical investigations of equipment deviations and troubleshooting • Manages programs and processes to ensure high quality of operations, equipment and compliance with codes and current Good Manufacturing Practices and Good Engineering Practices • Implement and integrate equipment and systems with minimal interruption to manufacturing operations. • Independently resolves a wide variety of issues of complex scope • Independently manages assigned projects through completion • Ensures solutions are consistent with organizational objectives • Provides experienced and expert guidance to internal teams Skills: Gmp, Production, Process improvement, Continuous improvement, qa procedures, procurement, vendor coordination, change management, increasing yields, Capa, Chemistry, Business operation, Quality control, Biotechnology Top Skills Details: Gmp,Production,Process improvement,Continuous improvement,qa procedures,procurement,vendor coordination,change management,increasing yields,Capa Additional Skills & Qualifications: Specific Education & Experience Requirements: • 10+ years of relevant experience and a BS or related fields. • 8+ years of relevant experience and a MA or MBA. • Has previous experience in biotech or pharmaceuticals industry. • Has previous experience in engineering in highly regulated manufacturing environments. Knowledge: • Entrepreneurial attitude; Anticipate, Easy to work with, incredible self-start who works tirelessly to achieve success. • Demonstrates in-depth knowledge of state of the art principles • Demonstrates in-depth knowledge of current Good Manufacturing Practices (GMPs). • Demonstrates extensive knowledge of industry practices. • Demonstrates excellent verbal, technical writing, and interpersonal communication skills. • Has proven analytical and conceptual skills. • Demonstrates ability to effectively manage multiple projects/priorities. • Demonstrates ability to understand key business processes and business areas • Demonstrates expertise in project management • Demonstrates the ability to work effectively in cross-functional teams Experience Level: Expert 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.