Omni Consulting ยท 14 hours ago
Senior Validation Engineer
Boston, MA
Full-time
Onsite
Senior Level
5+ years expOmni Consulting Services LLC is a woman and minority-owned engineering and consulting firm, specializing in comprehensive CQV and engineering solutions tailored exclusively for the dynamic life science industry. They are looking for a highly motivated mid-level CQV engineer to support their clients' project execution at bio-pharmaceutical manufacturing facilities, focusing on delivering commissioning and qualification activities.
Pharmaceuticals
Hiring Manager
Peter Broomes
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.), commercial-scale process equipment (washers, cold room chambers, autoclaves, bioreactors, chromatography, TFF, 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
Qualification
Required
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
Preferred
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
Company
Omni Consulting
Industry: Life-sciences/ Pharma/ Biotech Consulting Firm Omni Consulting Services LLC, a woman and minority-owned engineering and consulting firm, is your trusted partner for comprehensive CQV and engineering solutions tailored exclusively for the dynamic life science industry.
11-50 employees
H1B Sponsorship
Omni Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
Funding
Current Stage
Early StageLeadership Team
Dharti Pancholi
Founder and Chief Executive Officer
Company data provided by crunchbase