Senior Validation Engineer

Job Summary

Provide oversight and implementation of validation activities associated with computerized systems and equipment to ensure compliance with applicable Current Good Manufacturing Practice (CGMP) regulations, corporate policies, and site Standard Operating Procedures (SOP’s). Work closely with the operations and quality departments to develop validation deliverables, ensuring fit for purpose and testing requirements that are defined and follow the Master Validation Plan and applicable CGMP regulations.

Key Responsibilities and Duties:

•    Prepare validation deliverables for computerized systems and equipment, including Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports
•    Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-qualification (RQ) protocols, if applicable, for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.
•    Assist system SMEs in the preparation of test scripts comprising formal testing of functional system and regulatory requirements in conjunction with computerized system validation.
•    Oversee and/or perform test script execution.
•    Work with Operations and Quality to assess risk and impact with respect to proposed changes within the facilities and validated processes. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations.
•    Provide ongoing Qualification/Validation and other appropriate System Lifecycle training/education of staff.
•    Provide ongoing support of Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies.
•    Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner.
•    Participate in the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during validation efforts regarding equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues to ensure compliance with applicable regulatory requirements/guidelines, procedures, and policies.
•    Participate in the development of CAPA’s and assess the effectiveness of the corrective action. Schedule validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements.
•    Assist, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation.
•    Manage validation contractors, as needed.
•    Provide technical review of documents pre and post execution.
•    Perform all other related duties, as assigned.

Job Qualifications

•    Bachelor’s degree or equivalent in a scientific, Engineering, IT discipline, or related field.
•    Preference given to candidates with a minimum of 5 years validation related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Must have excellent oral and written communication skills. Strong documentation development and technical writing skills are critical to this position.
•    Must have in-depth knowledge of accepted industry practices and regulatory requirements that govern computer system validation in the pharmaceutical industry. 21 CFR Parts 210, 211, 820, 11, EU Annex 11, and applicable ICH and FDA guidance's.
•    Leadership ability, project management, and facilitation skills required. Must be proficient with Microsoft Office software (Word, Excel, PowerPoint). Must have good interpersonal, organizational, and analytical skills.

Compensation Data

The pay range for this position is $90,000 - $115,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.