They are a research driven biopharmaceutical group who is committed to building families worldwide. They strive to best address needs of patients and customers by collaborating as a team and continuously learning. They are committed to supporting all employees in their career development and make sure everyone receives the right level of support and progression.

Job Title: Process Engineer

Description:

• Coordinating efforts with end users and equipment fabricators

• Collaborate, review, and comment on equipment documentation (Design documents, Site Procedures (SOPs), and validation protocols

• Assist with equipment integration to site network, other systems, and site historian

• Plan site activities with vendors

• Facilitate FMEA and risk assessments on process equipment

• Support the validation team during execution of Installation and Operational Qualification (IQ/OQ) activities.

• Onsite support on off hours, nights, weekends, and holidays as needed to support the manufacturing production activities

• Support efforts for process equipment located within a cleanroom environment

• Participate in daily huddle meetings as a representative for process equipment

• Support site process improvement initiatives

• Complete investigations of process system deviations and implement corrective and preventive actions as required to mitigate future recurrence

• Manage relevant engineering activities and prioritize work to ensure site and project timelines are met. This will include direct assistance on the production floor.

• Partner with other departments and sites for special projects and quality issues, demonstrating technical proficiency, scientific creativity and collaboration

Skills:

process equipment, troubleshooting, automated equipment, filling machines, pharmaceutical manufacturing, aseptic, Manufacturing engineering, Engineering, Process engineering, equipment test, troubleshoot plc, hmi, human machine interface

Additional Skills & Qualifications:

• Bachelor’s degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines

• Minimum of five years of industry experience

• Minimum 5 years engineering experience in a pharmaceutical industry setting with a focus on aseptic processing and lyophilization

• Extensive knowledge of cGMP requirements and regulations for pharmaceutical manufacturing

• Ability to effectively communicate, interact, and collaborate with internal and external team members at all levels

• Strong analytical skills, hands-on troubleshooting skills and the capability to utilize analysis software and company quality system software

• Must possess tactical capabilities in organizing required tasks in executing complex project work

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.