Validation Engineer Lead jobs in United States
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Syner-G · 1 day ago

Validation Engineer Lead

positionPetersburg, VA
timeFull-time
remoteHybrid
seniorityMid, Senior Level
money$90K/yr - $150K/yr
date7+ years exp

Syner-G is a biopharma product development and delivery partner that focuses on enhancing the quality of life through breakthrough science and therapies. They are seeking a Validation Engineer Lead to oversee startup, commissioning, and validation processes while managing engineering documentation and collaborating with various teams to ensure project success.

Health CareManufacturingPharmaceutical
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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 skillsDetail-orientedProblem-solving abilitiesTeam collaboration

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

Generous flexible paid time off program
Company paid holidays
Flexible working hours
Fully remote work options for most positions
The ability to work 'almost anywhere'

Company

Syner-G

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Syner-G is a Strategic Development & Delivery Partner™ to biopharma innovators.
dateFounded in 2007
location
Southborough, Massachusetts, USA
people-size201-500 employees
web-link
https://synergbiopharma.com/

Funding

Current Stage
Growth Stage

Leadership Team

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Ron Kraus
Chief Executive Officer
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Prabu Nambiar
Founder, Strategic Advisor, Board Member
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Recent News

PRWeb
From Science to Success: Syner-G Announces New Brand & Service Model to Drive Biopharma Innovation
2025-10-23
Precedence Research
Biotechnology & Pharmaceutical Services Market Set to Surge from USD 76.51 Bn in 2024 to USD 130.56 Bn by 2034 at 5.48% CAGR
2025-09-29
PRWeb
Sequoia Biotech Consulting Rebrands as Syner-G BioPharma Group
2025-06-25
Company data provided by crunchbase