Validation Engineer

Boston, MA, US • Posted 30+ days ago • Updated 10 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Life Sciences
Spectrum
Regulatory Compliance
Regulatory Affairs
Recruiting
AIM
Project Implementation
Root Cause Analysis
Corrective And Preventive Action
Collaboration
Automated Testing
GMP
HVAC
Adobe AIR
SIP
Chromatography
HPLC
Good Manufacturing Practice
GDP
Pharmaceutics
Medical Devices
Mapping
Veeva
Virtual Machines
IDS
URS
Test Scripts
Management
SCADA
Turnover
Documentation
Testing
Manufacturing

Summary

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.
ssist 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:

HUs 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.
utoclaves.
HPLC.
Lyophilizer.

Requirements:

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.
bility to independently perform basic troubleshooting to rule out errors in setup, testing, protocol discrepancy, etc and propose solutions.

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: eb1d330e5a2d31de24da263fae08f608
Posted 30+ days ago

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Validation Engineer

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Job Details

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