QvalFocus Inc. · 23 hours ago
Senior Manufacturing Engineer
QvalFocus Inc. is seeking a senior, hands-on Manufacturing/Automation Engineer who can take full ownership of equipment and automated manufacturing line activities with minimal supervision. This role requires strong execution capability, independent problem-solving, and deep experience working in a GMP-regulated life sciences environment.
Responsibilities
Own equipment and automated manufacturing line modifications end-to-end (design → build → installation → FAT → commissioning → validation support)
Independently create, review, and update SOPs, URS/UURS, and engineering documentation
Source and order parts, install equipment, troubleshoot issues, and continuously refine system designs
Support commissioning, FATs, SATs, and validation activities in a GMP environment
Apply requirements-based engineering practices while ensuring quality, compliance, and data integrity
Lead and manage small to mid-size projects independently
Collaborate with Manufacturing, Quality, Validation, Maintenance, and other cross-functional teams
Provide hands-on support for automated equipment and manufacturing line optimization
Qualification
Required
7+ years of hands-on experience in manufacturing and/or automation engineering
Strong background in GMP-regulated life sciences (pharma, biotech, medical devices)
Proven ability to work independently with minimal supervision and strong ownership mindset
Solid understanding of validation, quality systems, and regulatory compliance expectations
Demonstrated experience modifying, upgrading, or redesigning automated manufacturing lines
Excellent troubleshooting and root cause analysis skills
Strong documentation and communication skills
Company
QvalFocus Inc.
QvalFocus: Focused on Delivering Quality that sets us Apart.
H1B Sponsorship
QvalFocus Inc. 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
2025 (35)
2024 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase