The Associate Validation Consultant brings 1–3 years of software validation experience to Strategic's life science consulting practice, executing computer system validation (CSV) and computer software assurance (CSA) activities under the guidance of a senior validation consultant.
This full-time position reports to the Director of Project Management and is a remote role.
ESSENTIAL FUNCTIONS
- Apply Strategic's validation standards and SOPs in all work, ensuring deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles, and escalate questions or gaps to the senior consultant
- Explain the use of Strategic's validation toolkits to clients and deliver validation engagements using them
- Maintain and update Strategic's validation toolkits under the direction of a senior consultant, including updates driven by software releases and changing regulations
- Execute validation test scripts, capture objective evidence in line with ALCOA+ principles, document deviations, and support results review
- Support client validation engagements as embedded staff augmentation, working within client QMS and SDLC constraints under senior oversight; a senior consultant retains client-facing accountability for deliverables
- Follow client SOPs and internal CSV/QMS requirements, and escalate questions, conflicts, or gaps to the senior consultant
- Participate in training and knowledge transfer with senior consultants, and contribute to delivery tasks supporting Strategic's CVaaS (Computer Validation as a Service) offering
MINIMUM QUALIFICATIONS
- 1+ year of experience in computer system validation (CSV), computer software assurance (CSA), quality assurance, or a related role in a regulated life science environment
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field (or equivalent experience), plus 1+ year in CSV, CSA, quality assurance, or a related role in a regulated life science environment
- Working knowledge of cGxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+, with a willingness to learn CSA and risk-based validation approaches
- Hands-on ability to execute validation protocols (evidence capture, deviation documentation, results review) and work from standard templates such as URS/FRS, RTMs, IQ/OQ/PQ, risk assessments, and validation summary reports
- Strong technical writing and attention to detail, producing accurate, audit-ready documentation
- Clear communication with QA, IT, and business stakeholders, the ability to adapt to client QMS and SDLC constraints, and the judgment to ask for guidance and escalate issues early
- Responsible use of approved AI and automation tools to improve productivity and quality, in line with company policy and data privacy requirements
PREFERRED EXPERIENCE
- Experience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers, including familiarity with 21 CFR Part 820 / QMSR and ISO 13485
- Prior consulting, staff augmentation, or other client-facing experience
- Industry certifications or coursework such as ISPE GAMP® Essentials, ASQ CQA, CQE, or CPGP
SUPERVISORY RESPONSIBILITIES
This position does not directly or indirectly supervise employees.
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Remote work model with primarily billable client engagement activity
While performing the duties of this job, the employee constantly operates a computer. Employees are regularly required to talk or hear and are frequently required to sit, stand; walk, use hands to finger, handle or feel; and reach with hands and arms.
This job operates in a professional remote office environment. This role routinely uses standard office equipment such as computers and phones.
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position. Hours of work are Monday through Friday, Regular Business hours, with some afterhours work as business needs require.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Travel
Travel is expected for this position, primarily for client meetings and project needs. Estimated travel: approximately
Compensation & Benefits
The compensation range for this role is $90,000 - $120,000 annually. The incentive pay is up to 20 % of base salary, tied to successful onboarding, training completion, and performance milestones. Compensation is commensurate with experience, certifications, and demonstrated expertise. We offer a comprehensive benefits package including medical, dental, vision, 401(k) with company match, paid time off, paid holidays, company-paid life and AD&D insurance, and additional voluntary benefits.
Other Duties:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Additional Information
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are made by people.
Requirements
The Associate Validation Consultant brings 1–3 years of software validation experience to Strategic's life science consulting practice, executing computer system validation (CSV) and computer software assurance (CSA) activities under the guidance of a senior validation consultant.
This full-time position reports to the Director of Project Management and is a remote role.
ESSENTIAL FUNCTIONS
- Apply Strategic's validation standards and SOPs in all work, ensuring deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles, and escalate questions or gaps to the senior consultant
- Explain the use of Strategic's validation toolkits to clients and deliver validation engagements using them
- Maintain and update Strategic's validation toolkits under the direction of a senior consultant, including updates driven by software releases and changing regulations
- Execute validation test scripts, capture objective evidence in line with ALCOA+ principles, document deviations, and support results review
- Support client validation engagements as embedded staff augmentation, working within client QMS and SDLC constraints under senior oversight; a senior consultant retains client-facing accountability for deliverables
- Follow client SOPs and internal CSV/QMS requirements, and escalate questions, conflicts, or gaps to the senior consultant
- Participate in training and knowledge transfer with senior consultants, and contribute to delivery tasks supporting Strategic's CVaaS (Computer Validation as a Service) offering
MINIMUM QUALIFICATIONS
- 1+ year of experience in computer system validation (CSV), computer software assurance (CSA), quality assurance, or a related role in a regulated life science environment
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related field (or equivalent experience), plus 1+ year in CSV, CSA, quality assurance, or a related role in a regulated life science environment
- Working knowledge of cGxP, GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+, with a willingness to learn CSA and risk-based validation approaches
- Hands-on ability to execute validation protocols (evidence capture, deviation documentation, results review) and work from standard templates such as URS/FRS, RTMs, IQ/OQ/PQ, risk assessments, and validation summary reports
- Strong technical writing and attention to detail, producing accurate, audit-ready documentation
- Clear communication with QA, IT, and business stakeholders, the ability to adapt to client QMS and SDLC constraints, and the judgment to ask for guidance and escalate issues early
- Responsible use of approved AI and automation tools to improve productivity and quality, in line with company policy and data privacy requirements
PREFERRED EXPERIENCE
- Experience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers, including familiarity with 21 CFR Part 820 / QMSR and ISO 13485
- Prior consulting, staff augmentation, or other client-facing experience
- Industry certifications or coursework such as ISPE GAMP® Essentials, ASQ CQA, CQE, or CPGP
SUPERVISORY RESPONSIBILITIES
This position does not directly or indirectly supervise employees.
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Remote work model with primarily billable client engagement activity
While performing the duties of this job, the employee constantly operates a computer. Employees are regularly required to talk or hear and are frequently required to sit, stand; walk, use hands to finger, handle or feel; and reach with hands and arms.
This job operates in a professional remote office environment. This role routinely uses standard office equipment such as computers and phones.
POSITION TYPE/EXPECTED HOURS OF WORK
This is a full-time position. Hours of work are Monday through Friday, Regular Business hours, with some afterhours work as business needs require.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Travel
Travel is expected for this position, primarily for client meetings and project needs. Estimated travel: approximately
Compensation & Benefits
The compensation range for this role is $90,000 - $120,000 annually. The incentive pay is up to 20 % of base salary, tied to successful onboarding, training completion, and performance milestones. Compensation is commensurate with experience, certifications, and demonstrated expertise. We offer a comprehensive benefits package including medical, dental, vision, 401(k) with company match, paid time off, paid holidays, company-paid life and AD&D insurance, and additional voluntary benefits.
Other Duties:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Additional Information
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are made by people.