What are the responsibilities and job description for the Senior Validation Engineer position at AllSTEM Connections?
Our team is seeking a highly skilled Senior Validation Engineer to oversee technical compliance and ensure the integrity of our manufacturing equipment and processes. In this role, you will serve as a subject matter expert for validation activities, leading complex investigations and maintaining a state of inspection readiness across the facility.
Key Responsibilities
- Quality Assurance & Validation Oversight
- Technical Review: Lead the review and approval of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols, including data analysis and final report generation.
- Change Management: Evaluate and approve Change Requests to ensure that modifications to equipment or systems do not compromise their validated state.
- Compliance Maintenance: Audit specifications, standard operating procedures (SOPs), and technical documents to ensure continuous adherence to regulatory standards.
- Investigations & Regulatory Compliance
- Root Cause Analysis: Lead deviation investigations and provide expert oversight for validation failure resolutions.
- Audit Support: Represent the validation department during internal and external regulatory inspections, clearly presenting concepts and technical approaches to auditors.
- Standards Advocacy: Champion local and corporate standards to ensure all site activities meet current industry benchmarks.
- Operational Excellence & Project Support
- Process Improvement: Identify and implement system enhancements prior to change control entry to optimize efficiency and compliance.
- Cross-Functional Coordination: Manage the Annual Product Review (APR) process, collaborating with various departments to ensure data is accurate and delivered on schedule.
- Strategic Communication: Liaise with Engineering, R&D, and Site Management to communicate validation requirements and project milestones.
Candidates must meet one of the following education and experience criteria:
- Bachelor's Degree (Chemistry, Engineering, or a related technical field) 8 years of relevant experience.
- Master's Degree (Chemistry, Engineering, or a related technical field) 6 years of relevant experience.
- PhD (Chemistry, Engineering, or a related technical field) 4 years of experience specifically focused on validation, quality, or drug development.
Core Competencies
- Demonstrated expertise in root cause analysis and technical writing.
- Strong understanding of regulatory requirements within a GxP environment.
- Commitment to workplace safety and rigorous technical standards. Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
_ English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
IN HOUSE
Branch Phone:
Location:
Houston, TX
Key Responsibilities
- Quality Assurance & Validation Oversight
- Technical Review: Lead the review and approval of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols, including data analysis and final report generation.
- Change Management: Evaluate and approve Change Requests to ensure that modifications to equipment or systems do not compromise their validated state.
- Compliance Maintenance: Audit specifications, standard operating procedures (SOPs), and technical documents to ensure continuous adherence to regulatory standards.
- Investigations & Regulatory Compliance
- Root Cause Analysis: Lead deviation investigations and provide expert oversight for validation failure resolutions.
- Audit Support: Represent the validation department during internal and external regulatory inspections, clearly presenting concepts and technical approaches to auditors.
- Standards Advocacy: Champion local and corporate standards to ensure all site activities meet current industry benchmarks.
- Operational Excellence & Project Support
- Process Improvement: Identify and implement system enhancements prior to change control entry to optimize efficiency and compliance.
- Cross-Functional Coordination: Manage the Annual Product Review (APR) process, collaborating with various departments to ensure data is accurate and delivered on schedule.
- Strategic Communication: Liaise with Engineering, R&D, and Site Management to communicate validation requirements and project milestones.
Candidates must meet one of the following education and experience criteria:
- Bachelor's Degree (Chemistry, Engineering, or a related technical field) 8 years of relevant experience.
- Master's Degree (Chemistry, Engineering, or a related technical field) 6 years of relevant experience.
- PhD (Chemistry, Engineering, or a related technical field) 4 years of experience specifically focused on validation, quality, or drug development.
Core Competencies
- Demonstrated expertise in root cause analysis and technical writing.
- Strong understanding of regulatory requirements within a GxP environment.
- Commitment to workplace safety and rigorous technical standards. Equal Opportunity Employer / Disabled / Protected Veterans
The Know Your Rights poster is available here:
_EEOC_KnowYourRights6.12.pdf
The pay transparency policy is available here:
_ English_formattedESQA508c.pdf
For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.
We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.
AllSTEM Connections participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
_Participation_Poster_ES.pdf
We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Additional Skills
(none specified)
AllSTEM Representative Contact Info
Account Executive:
IN HOUSE
Branch Phone:
Location:
Houston, TX
Salary : $162,200