What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Job Description
- specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of services, including facilities, utilities, process, and automation engineering, top-tier quality, compliance, and regulatory affairs consulting, and innovative recruiting solutions. Our commitment extends beyond consulting, as we aim to be the next-generation partner providing total talent solutions to our partners, ensuring success at every stage of their journey.
- We are looking for a highly motivated mid-level CQV engineer (5 Years of Experience) with good interpersonal skills to join Omni as a C&Q engineer / consultant supporting our clients' project execution at their pharmaceutical manufacturing facility. This position is a field-based, execution-oriented role and part of a project team focused on delivering commissioning and qualification activities.
- The ideal candidate will have hands-on experience with GMP systems, familiarity with utilities and automation-controlled process equipment and cleaning validation.
- we embrace diversity including valuing everyone's unique skills. Omni truly believe to grow together with our employees and clients; our employees are our assets! Matching experienced US residents and Canadian citizens are encouraged to apply.
- Assist in implementing acceptance criteria, specifications, root cause analysis and corrective action plans.
- Collaborate with Engineering, QA, Automation, and construction teams to ensure systems are delivered per GMP and project standards.
- AHUs and Cleanroom HVAC systems.
- Water for Injection (WFI).
- Clean steam.
- Compressed air and process gases.
- CIP/SIP systems.
- Fermenters.
- Chromatography skids.
- Tangential Flow Filtration (TFF) units.
- Buffer prep and hold tanks.
- Centrifuges.
- Formulation vessels and associated skids.
- Parts Washers.
- Autoclaves.
- HPLC.
- Lyophilizer.
- Experienced with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Bachelor's degree in Engineering or similar technical field.
- 5 years of commissioning, qualification and validation experience in Pharmaceutical/biotech and/or Medical Device industry.
- Must have experience with qualification, commissioning / decommissioning and validation for process support equipment and / or automation system and / or utilities systems.
- Experience with CTE (controlled Temperature Environment) temp. mapping is highly desired.
- 1 Years of Experience (YOE) with independent Cleaning Validation protocol generation and execution experience.
- Proficiency with Veeva VMS, Kneat, and or ValGenesis for protocol development, execution, and documentation.
- Familiarity with P&IDs, interpreting engineering and source documentation (URS, FS, Owner's Manual), and protocol execution standards in order to generate detailed test scripts to verify requirements are met.
- Must be able to communicate clearly (written, verbal), Collaborative mindset and ability to work autonomously and effectively within cross-functional teams.
- Must have experience working on and contributing to project teams.
- Ability to independently perform basic troubleshooting to rule out errors in setup, testing, protocol discrepancy, etc and propose solutions.
- Project experience in greenfield and or facility expansion projects.
- Exposure to operating equipment that is controlled by a building management/automation system (e.g. DeltaV, SCADA, Rockwell PAx).
- Experience using commissioning tracking tools or turnover documentation systems.
- Cleaning Validation of process equipment including experience performing cleaning cycle development, rinse sampling, surface swabbing, visual inspections to support cleaning verification or cleaning validation.
- Prior testing experience on systems that use Unicorn software.
- Experience executing Computer Software Assurance (CSA) testing for manufacturing process equipment.
- Experience performing periodic reviews to evaluate if the validated state has been maintained and the completion of requalification.