Come work for the leader in reproductive medicine and maternal health!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
Process engineering
Equipment test
Troubleshoot plc
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
