Process Validation Engineer

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

Azzur Group is looking for a skilled Process Validation Engineer to join our dynamic team. The Process Validation Engineer will play a pivotal role in validating and ensuring the robustness of manufacturing processes used in the pharmaceutical and biopharmaceutical sectors. This position is ideal for a detail-oriented individual with expertise in validation principles and a passion for supporting the production of safe and effective products.

Key Responsibilities:

• Develop, execute, and manage process validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Collaborate with cross-functional teams to gather necessary data for validation activities and ensure adherence to regulatory requirements and industry standards.
• Conduct process mapping and risk assessments to identify critical process parameters (CPP) and critical quality attributes (CQA).
• Analyze data from process runs to ensure stability and consistency of processes, identifying trends and patterns that may affect quality.
• Document validation processes in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Review and approve validation documentation, including reports, protocols, and related SOPs.
• Support change control processes and manage validation lifecycle activities.
• Provide training and guidance to staff on validation standards and practices.
• Act as a key liaison during internal and external audits, ensuring compliance with validation processes and documentation.

Requirements

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 4-7 years of experience in process validation within the pharmaceutical or biotechnology industry.
• In-depth knowledge of process validation guidelines, including 21 CFR Part 211, ISPE, and ASTM E2500.
• Familiarity with statistical analysis tools and methodologies for validation.
• Strong analytical skills with a detail-oriented approach.
• Excellent communication skills, both verbal and written, to effectively collaborate with diverse teams.
• Ability to work independently and manage multiple projects under tight deadlines.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.