validation engineer

Join Our Team at PSC Biotech®

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it's about more than just a job—it's about your career and your future.

Your Role

We are hiring an experienced Validation Engineer to support multiple commissioning, qualification, and validation projects.

• Develop and execute IQ, OQ, PQ, and PV protocols, test methods, procedures, reports, risk assessments, and so on for a range of pharmaceutical and manufacturing equipment, facilities, utilities, and associated systems.
• Contribute to the development of master plans and validation strategies for a variety of manufacturing processes, adhering to regulatory requirements and compliance.
• Collaborate with cross functional teams to ensure alignment and successful completion of validation activities and deliverables.
• Perform risk assessments and support risk mitigation strategies. Investigate, review, and efficiently close deviations.
• Provide support for regulatory inspections as needed.
• Identify potential risks/issues throughout validation lifecycle, effectively supporting change controls.
• Conduct periodic reviews and requalification assessments as needed.
• Ensure all required documentation is reviewed, approved, stored, and managed accurately.
• Collaborate with vendors and contractors to ensure that equipment and systems meet validation requirements and specifications.
• Drive continuous improvement initiatives to enhance validation processes, documentation practices, and compliance standards across the organization.
• Additional responsibilities as required to drive successful project completion.

Requirements

• Bachelor's degree in relevant engineering discipline.
• 5+ years in a equipment commissioning, qualification, and validation engineering role, including proven success developing and executing validation protocols in the pharmaceutical manufacturing industry.
• In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc.
• Experienced with validation of pharmaceutical manufacturing equipment, facilities, utilities, and computerized systems.
• Advanced understanding of validation principles and methodologies.
• Excellent technical writing skills. 5+ years of experience drafting, developing, reviewing, and authoring technical documentation including protocols, procedures, risk assessment, specification requirements, etc.
• Strong understanding of engineering specifications (URS, DS, FS, etc.)
• Detail-oriented with a focus on accuracy and compliance.
• Ability to manage multiple priorities and prioritize tasks effectively.
• Excellent communication and interpersonal skills.
• Strong analytical skills with the ability to problem-solve and troubleshoot effectively.