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Manufacturing Engineer

Job Description:

Our team is seeking a dynamic Manufacturing Engineer to provide ongoing commercial process support, improvement, Continuous Improvement (CI) initiatives, equipment selection / support, and scientific support to our portfolio of products that are in commercial or transitioning into commercial across various industries. The candidate will also ensure that all projects comply with cGMP, FDA, and DEA regulations and standards.

Qualifications:

• Able to select pumping, mixing and coating equipment to achieve desired manufacturing process.

• Assist and troubleshoot process / equipment issues that occur during commercial operations and product changeovers.

• Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability and qualification tied to changes on commercialized processes.

• Through CI activities enhance process conditions that increase quality, yield or reduce set-up and tear-down activities.

• Updates specifications, R&D Mfg. instructions, protocols, SOPs, process development reports, etc. used in enhancing existing commercial processes.

• Support and follow all regulatory compliance aspects, including following the necessary change control processes.

• Lead, research and write equipment specifications with support from R&D.

• Lead / support CI activities that increase efficiencies on commercial processes.

• Support Quality in NCM and CAPA investigations.

• Maintain accurate and complete records of development activities on commercialized processes.

• Support operations with qualification / PM, commercial manufacturing activities, etc.

• Interface and provide leadership to project teams, vendors and clients in all activities from re-development to on-going commercial production.

• Provide technical and/or scientific guidance to operations and internal teams when appropriate.

• Receive the hand-off of Developed Processes with robust control processes from Validation and R&D.

• Familiarity with flammable solvents and their safety codes and machine features.

Skills:

• 1+ years of experience in manufacturing process improvement/sustainability

• Strong technical writing skills

• Knowledge of the Pharma or medical device industry

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.