6245 - Solution Prep Principal Engineer / Lead Validation Engineer

Estados Unidos

Apex, 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 Solution Prep Principal Engineer with hands-on experience supporting solution preparation systems within biopharmaceutical manufacturing environments. This role will focus on solution preparation, buffer preparation, and media preparation unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting equipment startup and commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

SOLUTION PREPARATION PRINCIPAL ENGINEER RESPONSIBILITIES

COMMISSIONING, QUALIFICATION & VALIDATION

Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.
Author, review, and execute CQV lifecycle documentation including:
Commissioning test protocols
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Validation summary reports
Ensure validation documentation complies with cGMP regulations and internal quality procedures.
Participate in system impact assessments, risk assessments, and validation planning activities.

SOLUTION PREPARATION PROCESS SUPPORT

Provide technical support for solution preparation unit operations, including

systems such as

Buffer preparation systems
Media preparation systems
Solution preparation tanks and mixing systems
Single-use mixing systems
Transfer and hold systems
Support equipment startup and operational readiness for solution preparation processes.
Assist with troubleshooting and process verification during commissioning and qualification activities.

VENDOR & EQUIPMENT STARTUP

Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.
Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.
Participate in equipment startup, commissioning, and operational testing activities.

CROSS-FUNCTIONAL COORDINATION

Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.
Assist with deviation investigations, change control processes, and documentation updates.
Ensure CQV activities align with project schedules and operational readiness milestones.

DIGITAL VALIDATION SYSTEMS

Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.
Maintain data integrity, traceability, and compliance within digital validation systems.

REQUIREMENTS

Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related technical field
10+ years of role specific experience
Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments
Hands-on experience with solution preparation, buffer prep, or media prep systems
Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)
Ability to work independently while coordinating with cross-functional teams
Strong technical documentation and communication skills
Experience using digital validation platforms such as Kneat
Experience supporting FAT/SAT, commissioning, and equipment startup
Familiarity with single-use systems and biologics manufacturing processes
Experience working within biologics or cell culture manufacturing facilities
Onsite job requirement in Apex, 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

6245 - Solution Prep Principal Engineer / Lead Validation Engineer

Sobre a oportunidade

Company Culture Guidelines & Values

SOLUTION PREPARATION PRINCIPAL ENGINEER RESPONSIBILITIES

systems such as

REQUIREMENTS

Benefits

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