Role Summary:
We are currently seeking a Validation Engineer to join our Clients project team during the planning and documentation phase of a critical pharmaceutical installation. This role will initially focus on comprehensive documentation preparation and review, transitioning to active equipment validation on the manufacturing floor in the next project phase.
You will be involved in reviewing vendor and project documentation, drafting validation protocols, and participating in project planning meetings, with a strong emphasis on compliance, quality, and detail orientation. As the project advances into the execution phase, the role will shift to hands-on validation activities supporting equipment installation and qualification.
Key Responsibilities:
- Review vendor-supplied documentation and internal project validation documents.
- Draft and revise protocols, reports, and other validation documentation in line with GMP and regulatory requirements.
- Work within the NEAT electronic document management system for all documentation generation and review activities.
- Attend and contribute to planning and coordination meetings with cross-functional teams.
- Provide validation input during the equipment and utilities design and planning stages.
- Support execution of validation protocols once equipment is installed, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure compliance with cleanroom standards and aseptic techniques during floor-based activities.
- Collaborate closely with engineering, quality, and manufacturing teams to ensure validation activities align with project timelines and regulatory expectations.
Requirements:
Essential:
- Experience working in validation roles within the pharmaceutical industry, ideally with exposure to cleanroom environments.
- Strong documentation and technical writing skills.
- Experience reviewing vendor and project documentation.
- Ability to work effectively in cross-functional teams and participate in multiple project meetings.
- Proficient in the use of electronic document management systems (preferably NEAT).
- Understanding of GMP and validation lifecycle requirements.
Desirable:
- Previous experience with fill/finish operations, especially involving isolator technology, filling lines, or HVAC systems.
- Familiarity with working in environments involving duplicate manufacturing lines or mirrored equipment layouts.
- Exposure to or experience validating equipment and utilities in high-compliance, sterile environments.
Ideal Candidate Profile:
The ideal candidate will bring hands-on experience from a pharmaceutical or biopharmaceutical manufacturing environment, particularly in fill-finish operations. You’ll be comfortable working in cleanroom conditions, collaborating in a team-oriented setting, and managing multiple documentation tasks simultaneously. Experience with isolators, HVAC systems, or filling lines will be a strong advantage. A proactive approach and readiness to transition from planning to execution phases is essential.