Validation Engineer

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 Val Genesis 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. Delta
  
  V, 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.