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Description:

This position will have an area of focus on equipment functionality and operational requirements in a specific process flow, as well the design, optimization, and implementation of Manufacturing and GxP Laboratory equipment.

Responsibilities include but are not limited to:

• Responsible for creating and maintaining Process Flow Diagrams, Risk Assessments, Asset Standardization, and Master Specification Sheets.

• Support the evaluation, selection, and recommendation of process and laboratory equipment that meet quality/regulatory compliance for Phase 1 and 2 Clinical Manufacturing of Drug Substance and Drug Product.

• Responsible for creating and maintain OEM Files which include Equipment Turnover Packages, O&M Manuals, and Drawings.

• Be able to perform and deliver specific engineering project tasks as necessary.

• Represent the F&E team during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities.

• Perform Front-End Loading (FEL) and feasibility studies of equipment used in both GMP and cGLP applications.

• Responsible for process troubleshooting during startup of new and existing facilities and process/laboratory equipment.

• Responsible for analysis and upgrade of process and utility systems as needed.

• Responsible for the development of P&ID’s and Process Flow Diagrams.

• Provide technical input for analysis of process changes.

Additional Skills & Qualifications:

• Bachelor's Degree in Chemical Engineering (or other related field) with 2-4 years of experience (or equivalent combination of education and experience) in the design and construction of processing equipment and instrumentation in a manufacturing plant environment, preferably in the biotechnology or pharmaceutical industries.

• Experience supporting lab and process equipment within an FDA/EMA regulated environment.

• Auto Desk Fusion 360 or SolidWorks experience preferred.

• Experience in CAD design of process/laboratory equipment.

• Experience with lab/process equipment validation, calibration and performing risk assessments.

• Experience with automation systems is highly desired.

• Experience with cGMP Quality Systems in a biotech/pharmaceutical environment. This includes experience with authoring and executing equipment/system Change Controls, Deviations, and CAPAs.

• Intermediate computer skills using MS Office suite and Office 365 cloud environment.

• Exceptional attention to detail and follow-through.

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.