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Job Description

Day to Day :

Our client in Raleigh-Durham is seeing a downstream process automation DeltaV support Engineer to join their team. This individual will support the system integration management for downstream equipment and systems in the areas of Buffer Preparation/Hold, Purification Chromatography (LPC), Viral Filtration (VF), Ultrafiltration (UF), Diafiltration (DF), and Dispensing contained within the Drug Substance Manufacturing (DSM) area of the facility. Equipment is controlled primarily by a DeltaV DCS. The System integrator will update DeltaV configuration from code received from the corporate headquarters to align with site-specific equipment requirements. This role will require coordination with and management of the System Integrator.

The following scope will be provided by the Downstream Process Automation DeltaV Support Engineer:

Attend regularly scheduled project status meetings with Automation engineers and the System Integrator

Attend weekly DSM Automation Huddle meeting to provide status to the DSM Automation Team

Provide design review and input on Automation requirements for one or multiple process areas

Attend and provide feedback during System Integrator functional reviews of certain process areas

Review life cycle documentation

Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.

Support generation of Kneat documents.

Manage/oversee the System Integrators support of loop checks & commissioning activities for certain process areas

Coordinate with various project workstreams including Automation, CSV, CQV, Utilities, Process Engineering, and others as needed

We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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Skills and Requirements

Must Haves:

4+ years direct experience working with Emerson DeltaV DCS experience with configuration, updating batches, phases and recipes.

Experience in a cGMP pharmaceutical facility working with FDA regulations is required

Working knowledge of Kneat validation software is required

Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management Pluses:

Experience supporting upstream or downstream equipment

Knowledge with Drug Substance Manufacturing (DSM) would be beneficial

MasterControl, ComplianceWire, TrackWise, and Veeva experience is a plus null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].