STEM OPT Principal Solutions Engineer Jobs
Principal Solutions Engineer roles sit at the intersection of technical depth and client-facing strategy, making them a strong fit for STEM OPT graduates in computer science, engineering, or information systems. Your 24-month STEM OPT extension applies here, provided your employer is enrolled in E-Verify and your role aligns with your CIP code.
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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 CQV 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 CQV 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
- 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.
National (US) Range: $87,780 USD - $136,225 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 for further details.
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 CQV 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 CQV 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
- 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.
National (US) Range: $87,780 USD - $136,225 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 for further details.
See all STEM OPT Principal Solutions Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new STEM OPT Principal Solutions Engineer Jobs.
Get Access To All JobsTips for Finding STEM OPT Authorization as a Principal Solutions Engineer
Verify your CIP code covers solutions engineering
Check that your degree's Classification of Instructional Programs code maps to the technical requirements of a Principal Solutions Engineer role. Computer science, electrical engineering, and information systems CIP codes typically qualify, but confirm with your DSO before accepting an offer.
Confirm E-Verify enrollment before signing anything
Ask recruiters directly whether the company is enrolled in E-Verify before you reach the offer stage. Employers who hesitate or can't confirm enrollment cannot legally employ STEM OPT students, so treat this as a hard filter in your search.
Target companies with active DOL LCA filings
Companies that regularly file Labor Condition Applications for technical roles already have internal processes for work-authorization compliance. Use Migrate Mate to surface employers with verified STEM OPT hiring history specific to solutions engineering and pre-sales technical roles.
Build a portfolio of enterprise architecture work
Principal Solutions Engineer roles require demonstrated experience scoping complex deployments and leading technical discovery. Document specific implementations, stack decisions, and measurable outcomes you owned. Hiring managers at this level evaluate your ability to translate technical depth into business outcomes.
Submit your I-983 training plan before your start date
Your employer must sign and return the I-983 before you begin working under the STEM OPT extension. Define your learning objectives around solutions design, enterprise sales cycles, and cross-functional collaboration so the plan reflects genuine skill development USCIS expects.
Time your STEM OPT filing around offer timelines
File your STEM OPT extension with USCIS at least 90 days before your initial OPT expires. Principal Solutions Engineer hiring cycles at enterprise companies can run 8 to 12 weeks, so starting your extension application early prevents a gap between your offer date and your authorized start date.
Frequently Asked Questions
Does a Principal Solutions Engineer role qualify for the STEM OPT extension?
Yes, if your degree falls under an eligible STEM CIP code and your job duties align with that field. Principal Solutions Engineers typically hold degrees in computer science, electrical engineering, or information systems. Your DSO will confirm the match between your degree's CIP code and the role's technical requirements before recommending the STEM OPT extension to USCIS.
What E-Verify obligation does my employer have for my STEM OPT?
Your employer must be enrolled in E-Verify before your STEM OPT extension can be authorized. This is a federal requirement, not a company policy. You can ask your recruiter or HR contact to confirm enrollment status during the offer stage. Employers who are not enrolled cannot sponsor STEM OPT students, regardless of their willingness to hire international talent.
What goes into the I-983 training plan for a Principal Solutions Engineer?
The I-983 must describe the skills you'll develop, how the role connects to your STEM degree, and how your employer will evaluate your progress. For Principal Solutions Engineers, this typically covers enterprise architecture, technical pre-sales methodology, and solutions design. Both you and your employer's authorized signatory must complete and sign the form before your extension start date.
How does cap-gap protection work if my H-1B is selected while I'm on STEM OPT?
If you file an H-1B visa petition during your STEM OPT period and it's selected in the lottery, cap-gap protection automatically extends your work authorization through September 30 of that fiscal year. You can continue working as a Principal Solutions Engineer under cap-gap without interruption, as long as your employer maintains E-Verify enrollment and your I-983 remains active.
Where can I find Principal Solutions Engineer jobs where employers already understand STEM OPT?
Migrate Mate filters for employers with active E-Verify enrollment and a history of hiring STEM OPT students, so you're not manually vetting each company's compliance posture. Searching on Migrate Mate shows you Principal Solutions Engineer roles where the employer already understands the extension process, which significantly reduces friction at the offer and onboarding stages.