6243 - Downstream Principal Engineer / Lead Validation Engineer

Estados Unidos

Holly Springs, North Carolina, United States

Sobre a oportunidade

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values

We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise

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 RESPONSIBILITIES

COMMISSIONING 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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range $107,800—$168,011 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice apply.workable.com/verista/ccpa_policy?lng=en for further details.

For more information about our company, please visit us at Verista.com apply.workable.com/verista/

Idiomas

6243 - Downstream Principal Engineer / Lead Validation Engineer

Sobre a oportunidade

Company Culture Guidelines & Values

DOWNSTREAM PRINCIPAL ENGINEER RESPONSIBILITIES

REQUIREMENTS

Benefits

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