What are the responsibilities and job description for the IT/OT Validation Engineer - Biopharma position at Zachary Piper Solutions, LLC?
Job Details
IT/OT Validation Engineer - Biopharma
Requirements:
Compensation:
- Provide validation and technical support for IV, OV, and PV protocols, including preparation, execution, data analysis, and report writing.
- Manage Change Requests (CRs) related to project validation.
- Perform compliance and technical reviews/approvals of protocols and data. Author key validation documents such as Implementation Plans (IMPL) and Validation Plans (VPL).
- Independently author and execute IV, OV, and PV protocols for direct impact systems/processes within approved timeframes.
- Ensure validation protocols comply with local, corporate, and regulatory standards.
- Lead investigations into validation failures and non-conformities using root cause analysis.
- Create and update validation procedures and configuration item lists (CILs).
- Work with IT systems (PAS-X, SAP, Aveva PI) and computerized equipment (Autoclaves, Packaging, Assembly, Filling, Cart Washer, Utensil Washer, CIP/SIP, Formulation).
- Participate in FAT, SAT commissioning efforts for computerized equipment and automation systems, transitioning to validation ownership.
- Identify process improvements before equipment, systems, or processes are placed under change control.
- Assist in developing and improving system user requirements.
- Coordinate with IT and Automation teams to ensure validation efforts are met.
- Lead validation activities as assigned by the project manager.
Requirements:
- BA/BS degree in Engineering, Computer Science, or a related technical field, or equivalent work experience.
- Minimum of five years of experience in validation or quality-related disciplines in a pharmaceutical environment.
- Knowledge of regulatory requirements and industry standards (21 CFR Part 11, GAMP5, ISO, FDA, ICH).
- Experience with root-cause analysis techniques.
- Strong leadership and project management skills.
- Ability to write technical documentation based on equipment manuals.
- Experience in pharmaceutical manufacturing and GMP concepts.
- Ability to manage multiple tasks and prioritize based on process needs.
- Strong skills in change management.
Compensation:
- Compensation Range: $75-85/hr
- Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Salary : $75 - $85
