Description:

Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity. Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing. Performs or manages process validations (IQ/OQ, OQ, PQ). Troubleshoot production line issues related to yield, quality, and throughput. Leads scaling up processes from development to full scale manufacturing. Supports evaluation of NCMR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers/Suppliers. Creates/Updates manufacturing instructions, routings, bills of materials and SOPs.

Skills:

process validation, class iii medical devices, product transfer, implant

Top Skills Details:

process validation,class iii medical devices,product transfer

Additional Skills & Qualifications:

BA/BS in life sciences or engineering (Biomedical, Manufacturing, Mechanical). 4 years of experience of medical device manufacturing - class 3 preferred (live implants) Experience managing contract manufacturers Experience Process Validations at external suppliers (CMO). Experience transferring product from R&D to production

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.