Job Description
Job Title: Validation Lead
Location: REMOTE
Industry: Pharmaceutical / Life Sciences
Job Overview:
The Validation Lead will support the creation, editing, updating, and routing of validation documentation while providing Software Development Lifecycle (SDLC), computer system validation, and regulatory compliance expertise. This role will help define validation strategies for new system implementations and maintain existing systems in an audit-ready, validated state in alignment with corporate and FDA guidance. Preference will be given to candidates with 7+ years of computer system validation experience, especially those with pharma experience.
Responsibilities:
We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:
Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.
Location: REMOTE
Industry: Pharmaceutical / Life Sciences
Job Overview:
The Validation Lead will support the creation, editing, updating, and routing of validation documentation while providing Software Development Lifecycle (SDLC), computer system validation, and regulatory compliance expertise. This role will help define validation strategies for new system implementations and maintain existing systems in an audit-ready, validated state in alignment with corporate and FDA guidance. Preference will be given to candidates with 7+ years of computer system validation experience, especially those with pharma experience.
Responsibilities:
- Create, edit, update, and route validation documents.
- Provide SDLC and validation expertise with regulatory compliance guidance.
- Determine validation strategies for implementing new systems and maintaining existing systems.
- Help keep systems audit ready and in a validated state.
- Write requirements and test scripts, as needed.
- Manage multiple projects and support project implementation in Agile or waterfall environments.
- Support document management, formatting, training, and customer service-related activities.
- Bachelor’s degree in Journalism, English, Communications, Technical Writing, Computer Science, Teaching, Electronics, Education, or a related field.
- 7+ years of computer system validation experience preferred.
- Experience in pharmaceutical, life sciences, or regulated environments.
- Knowledge of GCP, GLP, GMP, 21 CFR Part 11, Computer System Validation (CSV), Quality Assurance (QA), and compliance practices.
- Strong technical writing, document management, training, project implementation, and customer service skills.
- Detail-oriented, resourceful, diplomatic, timely, responsive, trainable, diligent, and honest.
- Required tools: MS Word, MS Excel, and MS Outlook.
- Preferred tools: Jira, Application Lifecycle Management (ALM), MS PowerPoint, Veeva Quality Docs, and ServiceNow.
We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:
- Robust Health Insurance
- 401(k) plan
- PTO accrual
- Paid holidays
- Excellent cash-based referral program
Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.
Numbers & Facts
| Location | Indianapolis, IN (Remote) |
| Industry | Staffing/Employment Agencies |
| Company Size | 50 to 99 employees |
| Year Founded | 2014 |
| Website | http://www.insyncstaffing.com/default.html |
About Company
We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible.
inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced.
The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.
Skills
- Agile Programming Methodologiesunmatched
- Atlassian JIRAunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Code of Federal Regulationsunmatched
- Computer Scienceunmatched
- Computer Systemsunmatched
- Customer Relationsunmatched
- Customer Support/Serviceunmatched
- Customer Trainingunmatched
- Document Managementunmatched
- Documentation Formatunmatched
- Editingunmatched
- Electronicsunmatched
- English Languageunmatched
- FDA (Food and Drug Administration)unmatched
- GCP (Good Clinical Practices)unmatched
- GLP (Good Laboratory Practices)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Health Insuranceunmatched
- Information Technology & Information Systemsunmatched
- Information Technology/Systems Auditunmatched
- Journalismunmatched
- Microsoft Excelunmatched
- Microsoft Outlookunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Multitaskingunmatched
- Project/Program Managementunmatched
- Quality Assuranceunmatched
- Regulatory Complianceunmatched
- Requirements Managementunmatched
- ServiceNowunmatched
- Software Development Lifecycle (SDLC)unmatched
- Support Documentationunmatched
- System Validationunmatched
- Systems Maintenanceunmatched
- Technical Recruitingunmatched
- Technical Writingunmatched
- Test Scriptsunmatched
- Training/Teachingunmatched
- Validation Documentationunmatched
- Visual Studio Application Lifecycle Management (ALM) (fka Visual Studio Team System / VSTS )unmatched
- Waterfall Model of Software Developmentunmatched
- Writing Skillsunmatched
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