Process Engineer – Upstream/Downstream Manufacturing

Intellectt Inc

Holly Springs, US

On-site

Why this role

Pace

Fast Paced

Collaboration

High

Autonomy

Medium

Decision Impact

Team

Role Level

Individual Contributor

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

support startup, commissioning, and operational readiness activities
assist with equipment qualification
participate in deviation resolution and CAPA implementation

Typical background

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field

Transferable backgrounds

Coming from process engineer
Coming from quality assurance engineer

Skills & requirements

Required

Process EngineeringBiopharmaceutical ManufacturingEquipment StartupTroubleshootingProcess OptimizationGMP ComplianceCollaboration

Preferred

Automation/control SystemsBiologics Manufacturing FacilitiesFat/satEngineering WalkdownsTurnover Activities

Stack & domain

Biopharmaceutical ManufacturingUpstream BioprocessingDownstream PurificationBioreactorsChromatography SystemsFiltration SystemsCip/sip OperationsAutomation/control SystemsTroubleshootingProcess OptimizationBiopharmaceuticalsPharmaceuticals

About the role

Original posting from Intellectt Inc via Indeed

Process Engineer – Upstream/Downstream Manufacturing
Location: Holly springs, NC
Duration:12+months
Job Summary
We are looking for self-driven Process Engineers with strong biopharmaceutical manufacturing experience to support a greenfield expansion project in North Carolina. Candidates should possess hands-on expertise in upstream and downstream process operations, equipment startup, troubleshooting, and process optimization within GMP environments.
Key Responsibilities
Support startup, commissioning, and operational readiness activities for manufacturing process systems.
Provide technical support for upstream and downstream operations.
Assist with equipment qualification, process troubleshooting, and engineering investigations.
Collaborate with CQV, manufacturing, automation, and quality teams.
Review process flow diagrams, P&IDs, batch records, and technical documentation.
Support scale-up, tech transfer, and process optimization activities.
Ensure compliance with GMP standards and safety procedures.
Participate in FAT/SAT, engineering walkdowns, and turnover activities.
Support deviation resolution and CAPA implementation.
Required Experience
5+ years of Process Engineering experience in biotech or pharmaceutical manufacturing.
Strong experience with:
Upstream bioprocessing
Downstream purification
Bioreactors
Chromatography systems
Filtration systems
CIP/SIP operations
Experience supporting greenfield or large capital projects.
Knowledge of GMP manufacturing operations and validation practices.
Ability to work independently in fast-paced project environments.
Preferred Qualifications
Experience with biologics manufacturing facilities.
Familiarity with automation/control systems.
Strong troubleshooting and process optimization capabilities.
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biotechnology, or related field.
Pay: $45.00 - $50.00 per hour
Work Location: In person

Source: Intellectt Inc careers (Indeed)