Validation Engineer I (Rochester)

Why Us?

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Validation Engineer I evaluates and performs specified validations leading to the accurate and reliable validation of products, processes, equipment, facilities, and systems; assists / performs development of studies / cycles for new processes; helps troubleshoot product problems related to validation; performs testing and documents results for review by site, corporate and government review. Further responsible for providing supporting protocol rationales / justifications for the chosen validation methodology / approach.

Participates in programs to achieve departmental objectives. Records and reports results. Notes unusual results and notifies management for evaluation. Assists with writing validation documents.

In partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Job Description

Validation Protocols

• Generates validation protocols, and summarizes studies to ensure consistency of data production and compliance with manufacturer and Par Sterile Products specifications, with current Good Manufacturing Practices, and national standards
• Responsible for confirming all communicated validation plans to applicable management
• Provides technical assistance in the form of rationales or validation studies to support acceptability of the manufacture of products at Par Sterile Products
• Assists with development of validation protocols, performs testing and writes validation reports for various equipment / processes pertaining to the manufacturing area.
• Helps to determine process capability of new equipment though execution of approved protocols and assures that defined parameters are incorporated into respective operating procedures
• Responsible for effectively adopting modern validation techniques, current industry practices, risk management principles, science-based approaches and a strong understanding of processes and equipment.
• Troubleshoots and resolves issues as needed

50%

Production Process

Qualification

25%

Project Management

15%

Deviation Investigation

10%

Cross-Functional Activities

Continuous

Reports

Continuous

Standard Operating Procedures

Continuous

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP / GLP / GCP, Lean Manufacturing, Six-Sigma, etc.

Skills & Abilities

Often referred to as competencies, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

Physical Requirements

Disclaimer : The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

EEO Statement :

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.