Validation Engineer Lead jobs in United States
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Syner-G · 4 hours ago

Validation Engineer Lead

Syner-G is a company focused on enhancing the quality of life through breakthrough science and life-enhancing therapies. They are seeking a Validation Lead to oversee the startup, commissioning, and validation of building and utility systems, while generating and managing engineering lifecycle documentation.

Health CareManufacturingPharmaceutical

Responsibilities

Lead and execute startup, commissioning and validation of building and utility systems, process equipment, and/or laboratory instrumentation
Generate and manage engineering lifecycle documentation, including impact assessments, URS/FRS, FAT/SAT documentation, ETOPs, P&IDs, and other technical documents
Conduct drawing walkdowns and verify field installation of equipment and utilities
Generate and execute protocols and reports
Collaborate with cross-functional teams to ensure successful project completion
Communicate effectively with stakeholders to provide updates and address issues
Ensure compliance with safety standards and regulations

Qualification

Equipment startup experienceValidation lifecycle knowledgeEngineering documentation managementBMSPCSCMMS systemsContinuous manufacturing processesPATProcess controlsCommunication skillsProblem-solving abilitiesOrganizational skillsTeamwork ability

Required

Bachelor's Degree in Engineering or a related field
7-10 years of hands-on equipment startup and validation experience
Experience with generating and managing engineering lifecycle documentation
Experience with drawing walkdowns and verification of field installation
Experience with BMS, PCS, and CMMS systems
Strong understanding of validation lifecycle for equipment and utilities
Excellent documentation and organizational skills
Ability to work independently and as part of a team
Strong communication and interpersonal skills
Detail-oriented with strong problem-solving abilities

Preferred

Experience with continuous manufacturing processes is desired
Experience with PAT and process controls and instrumentation is desired

Benefits

Market competitive base salary
Annual incentive plan
Robust benefit offerings
Generous flexible paid time off program
Company paid holidays
Flexible working hours
Fully remote work options for most positions
Ability to work 'almost anywhere'

Company

Syner-G

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Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.

Funding

Current Stage
Growth Stage

Leadership Team

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Ron Kraus
Chief Executive Officer
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Prabu Nambiar
Founder, Board Member
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Company data provided by crunchbase