Join Our Validation Team

Role Description

This is a full-time on-site role for a strong CQV Engineer located in Boston, MA.  

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.

At Omni, 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!

Responsibilities

· Provide support to decommissioning, commissioning and qualification activities including writing protocols, reports, executing, development of documentation.

· Provide qualification support for our clients including Automations systems (DeltaV, Rockwell etc.), QC lab equipment (HPLC, Eliza etc.), process equipment (washers, cold room chambers, autoclaves etc.) and /or utilities (WFI, gases, HVAC etc.).

· Assist in generation and execution of commissioning and qualification documentations for accuracy, technical soundness and compliance to both site and regulatory guidelines.

· Perform P&ID walkdowns, loop checks, component verifications, and functional testing.

· Participate in FAT/SAT, equipment installation verification, punch list tracking, and issue resolution.

· Assist with generating turnover packages (TOPs), traceability matrices, and related documentation.

· Projects may include commissioning new facilities/equipment and QC equipment.

· Review documentation and drawings to ensure that documents meet quality and are in full compliance with regulations and standards.

· Support commissioning team to investigate, troubleshoot problems and determine possible solutions arising from equipment/system failures.

· Support execution of commissioning plans and protocols such as URS, FS, IQ, OQ, PQ, TM, Commissioning Plan, Q/VSR and revise as needed.

· Experience with CTEs (freezers, refrigerators, incubators, cold room, stability room etc.) and CSV (LIMS) etc. is a plus.

· Experience with independently performing empty and loaded chamber temperature mapping including worst-case item and load pattern justification.

· Support continuous qualification or maintenance for equipment, facility and process through the change control program.

· Help analyzing commissioning data, prepare reports, and make recommendations for changes and or/improvements.

· 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.

Clean Utilities Systems in Scope:

• AHUs and Cleanroom HVAC systems
• Water for Injection (WFI)
• Clean steam
• Compressed air and process gases
• CIP/SIP systems

Process Equipment in Scope:

• Fermenters
• Chromatography skids
• Tangential Flow Filtration (TFF) units
• Buffer prep and hold tanks
• Centrifuges
• Formulation vessels and associated skids
• Parts Washers
• Autoclaves
• HPLC
• Lyophilizer

Preferred Experience

• 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

Qualifications

• 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.

Applicants can contact the following e-mail to submit resumes and for inquiries on the job posting: recruiting@omniconsultingservice.com

We prefer candidates already located in MA, or willing to relocate. Exceptions may be made for strong candidates.

Some shifts or weekend work may be involved.