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Downstream Principal Scientist Jobs (NOW HIRING)

Merck & Co.

In this Associate Principal Scientist role, the successful candidate will apply mechanistic modeling and numerical simulation to downstream biologics processes, with a focus on preparative ...

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Merck & Co.

In this Associate Principal Scientist role, the successful candidate will apply mechanistic modeling and numerical simulation to downstream biologics processes, with a focus on preparative ...

New

MSD

In this Associate Principal Scientist role, the successful candidate will apply mechanistic modeling and numerical simulation to downstream biologics processes, with a focus on preparative ...

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Merck

In this Associate Principal Scientist role, the successful candidate will apply mechanistic modeling and numerical simulation to downstream biologics processes, with a focus on preparative ...

New

Merck & Co.

In this Associate Principal Scientist role, the successful candidate will apply mechanistic modeling and numerical simulation to downstream biologics processes, with a focus on preparative ...

New

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Downstream Principal Scientist information

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How much do downstream principal scientist jobs pay per year?

As of Sep 11, 2026, the average yearly pay for downstream principal scientist in the United States is $144,009.00, according to ZipRecruiter salary data. Most workers in this role earn between $117,500.00 and $169,000.00 per year, depending on experience, location, and employer.

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Infographic showing various Downstream Principal Scientist job openings in the United States as of August 2026, with employment types broken down into 89% Full Time, 9% Part Time, 1% Temporary, and 1% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $144,009 per year, or $69.2 per hour.

6243 - Downstream Principal Engineer / Lead Validation Engineer

Holly Springs, NC

Verista, Inc.
Pharmaceutical and Medicine Manufacturing • 201 - 500 employees
Learn more about Verista, Inc.external

Full-time

Re-posted 8 days ago

Job description

We are seeking a Downstream Principal Engineer is responsible for overseeing the commissioning and qualification of downstream systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.

Downstream Principal Engineer Responsibilities:Downstream System Leadership
  • Serve as the commissioning and qualification lead for Downstream systems (responsibilities described below).
  • Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems.
C&Q Lead ResponsibilitiesCommissioning and Qualification Documentation
  • Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
  • Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
  • Engage with design engineers and SMEs to clarify system intent and operational requirements.
  • Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.
  • Create Commissioning Test Plans that translate design intent into testable steps.
  • Coordinate with the Automation Team to incorporate all automation functional testing.
  • Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.
  • Develop Installation, Operational, and Qualification (IOQ) protocols.
  • Prepare and submit summary reports documenting commissioning and qualification activities.
System Ownership and Execution
  • Take custody of the system post-construction and maintain ownership through C&Q completion.
  • Perform Lockout/Tagout (LOTO) for system safety.
  • Conduct pre-startup safety checks and risk assessments.
  • Prepare daily pre-task plans and verify team readiness for safe execution.
  • Attend daily commissioning meetings to coordinate activities.
  • Execute commissioning and IOQ protocols.
  • Resolve issues arising during execution.
  • Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline
  • 10+ years of role specific experience
  • Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments
  • Hands-on experience with downstream bioprocess equipment and purification systems
  • Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)
  • Ability to work independently while collaborating with cross-functional teams
  • Strong documentation, organizational, and communication skills
  • Experience with digital validation systems such as Kneat
  • Experience supporting FAT/SAT, commissioning, and equipment startup
  • Familiarity with risk-based validation approaches
  • Experience in biologics manufacturing or monoclonal antibody production environments
  • Onsite job requirement in Holly Springs, NC

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