Experience Inc. Jobs

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. This position reports directly to the Manager of Process Engineering and will work closely with all members of the Engineering, Quality, IT, Validation, Facilities, Lab Operations, and the Manufacturing Operations groups to meet user requirements and optimal function of all Manufacturing, Laboratory and Building Space criteria. 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. Example of utility systems include: Autoclaves, WFI, RODI, HVAC, CCA, and steam generation. Example of process systems include both Upstream (Bioreactors, Incubators, and others), Downstream (Centrifugation, Chromatography, Filtration), and supporting lab equipment (Temperature control units, Cell counters, HPLC’s, etc). • Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities. • Ensure that all appropriate documentation, drawings specifications are generated in compliance with company procedures and statutory requirements (US FDA and ISO). • Responsible for the development of P&ID’s and Process Flow Diagrams. • Provide technical input for analysis of process changes.

Skills:

GMP, Manufacturing process, Process engineering, Process Flow, Risk Assessment, GLP, Process System, process design, manufacturing environment, Lab Equipment Validation, quality system, Change Control, Deviation, CAPA, Asset Standardization, OEM, FDA, EMA, Auto Desk Fusion 360, SolidWorks, CAD Design, Equipment Validation

Top Skills Details:

GMP,Manufacturing process,Process engineering,Process Flow,Risk Assessment,GLP,Process System,process design,manufacturing environment,Lab Equipment Validation,quality system,Change Control,Deviation,CAPA

Additional Skills & Qualifications:

Minimum requirements: • 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 as a member of a functional team, helping with on-site issues that present themselves on a day-to-day basis. • 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. • Strong process/laboratory equipment technical problem-solving abilities. • Experience with automation systems is highly desired. This does not include the ability to execute computer/IT programming but the understanding of building automation systems and process/equipment control systems. • 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. • Effective technical writing and presentation skills. • Knowledge of FDA regulatory requirements.

Experience Level:

Entry Level

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.