Sr. Computer System Validation Specialist

PERMANENT JOB OPENING (DIRECT HIRE)

Our client – a global and growing BioPharma CDMO company needs a Sr. Computer System Validation Specialist with Pharmaceutical Industry experience at their expanding plant in WA state, Excellent salary up to $130K+ with excellent Benefits (start Day 1) + Generous Relocation Package. Client will support H1B visa transfer if needed.

Job Posting # 2727

Job Title: Sr. Computer System Validation Specialist

Location: Spokane, WA

Relocation: YES – The client offers a generous package for relocation assistance.

Compensation: Salary range up to $130K

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering, Maintenance and Validation group

This role will report to the Manager of Validation

Note 1: The company recently completed their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are currently expanding again with a 4th line at this growing plant site.

Note 2: Client will support transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Note 3: Client will consider 12+ years of experience without a degree.

Job Description:

Responsible for the computerized system validation and data integrity at the plant site.

The job functions include periodic review and audit trail reviews. Drafting, reviewing, and executing equipment-specific test plans.

Drafting and reviewing user requirement specifications, risk assessments, traceability matrix, and qualification protocols – including test plans and acceptance reports.

This person ensures the site’s data integrity strategy is sound and incoming systems are appropriately qualified and requalified to meet 21CFR and EMA Annex 11 requirements.

Perform Periodic Reviews and Audit Trail Reviews of computerized systems.

1. Write and review documents to support the qualification of a computerized system.
2. Validation Plan
3. User Requirements Specification
4. Risk Assessment
5. Traceability Matrix
6. Qualification Protocol
7. Qualification Test Plan
8. Qualification Acceptance Report
9. Validation Plan Acceptance Report
10. Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.
11. Write and review CSV SOPs.
12. Partner with other departments to ensure the site is compliant.

Provide support for computerized systems and data integrity strategy during audits, deviations, and investigations.

Candidate Must Have:

• Bachelor’s degree in any technical field. (No Degree will be considered for 12+ years of experience)
• Minimum 7 years of computer system validation experience in a pharmaceutical plant environment.
• CSV Experience with plant systems - PLC (A/B), HMI, Environmental Monitoring Systems, Building Management Systems, etc.
• Experience with technical writing, building and manufacturing computer control processes/systems.

Candidate-Nice to Have:

• CSV Experience with plant systems - PLC (A/B), HMI, Environmental Monitoring Systems, Building Management Systems, etc.
• GAMP 5 Certification
• Experience with Data Integrity, CSV, Software Validation, GMP records storage and SAP.

Keywords: CSV, Computer validation, SAP, PLC, CAPA, HVAC, Plant, HMI, SCADA IQ, OQ, PQ