Validation Engineer

Job Title: Validation   Engineer

Location: West Point PA (Onsite)

Duration: Contract

Job Description Summary

The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and processes.

Roles & Responsibilities:

• Develops a tailored approach for each project they are assigned including assessing vendor validation packages, performing gap analysis to User Requirements, developing plans and protocols using a risk-based approach that comply with company policies and procedures, and completing trace matrices.
• Reports on progress and roadblocks to the project team(s).
• Develops Commissioning and Qualification policies and procedures to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
• Development, execution, and management of small to medium size projects.
• Manages CQV contractors to perform tasks as required.
• Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices.
• Validation using risk-based approach (FMEA, PHA, etc.). Performs risk assessments to confirm safe and compliant designs and recommend additional controls.
• Reviews project documentation (URS, FRS, Technical Specifications, Functional Specifications).
• Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information.
• Partners with Quality to ensure a quality and compliant manufacturing environment.
• Manages workload to ensure timely approval of validation testing and documentation.
• Supports the validation department during inspections or audits as a Subject Matter Expert.
• Other related duties as assigned

Requirements:

• 7 +  years of experience in the engineering design and support or qualification of commercial grade pharmaceutical or biotechnology process equipment and utilities.
• Ability to read/interpret engineering drawings and design documents.
• Excellent technical writing and verbal communication skills.
• People oriented and a team player
• Proficient in Microsoft Word, Excel, PowerPoint, and Project.
• In-depth knowledge of FDA and EMEA regulations particularly 21 CFR part 11, 210, 211, Annex 1.
• Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.