Senior CQV and Packaging Engineer
About the job
- Be an effective and independent, seasoned lead contributor who requires minimal to no supervision and delivers results.
- Bachelor’s degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field.
- Have a minimum of 7+ years of experience in the biotechnology or pharmaceutical industries.
- Have a minimum of 3+ years of experience in packaging validation, including filling and capping processes, isolators, drop testing, stress testing, and packaging systems.
- Possess strong technical writing and protocol/report development skills.
- Be able to interpret complex data and resolve validation issues.
- Have effective English-native communication and cross-functional collaboration skills.
- Be proficient with validation lifecycle management systems and quality management systems; experience with TrackWise, Kneat, or Veeva is a plus.
- Develop and execute commissioning, qualification, and validation protocols, reports, and risk assessments in accordance with client procedures and current good manufacturing practice, Food and Drug Administration, European Medicines Agency, and other regulatory guidelines.
- Coordinate validation activities with Manufacturing and Quality Assurance to ensure proper execution.
- Investigate and support the resolution of protocol deviations and nonconformities.
- Support change control activities related to system and equipment modifications.
- Write and maintain standard operating procedures related to system and equipment operation and maintenance.
- Ensure documentation meets internal quality standards and audit readiness.
- Experience with TrackWise, Kneat, or Veeva validation lifecycle management and quality management systems.
About the company
VTI Life Sciences provides validation and compliance services across the pharmaceutical and biotech sectors. They offer a full range of services including computer validation, cleaning validation, process validation, clean room certification, temperature mapping, and qualification of processes, equipment, and facilities. Their work involves conducting and documenting tests, audits, and qualifications to show a facility and its systems meet regulatory standards and quality requirements. The company differentiates itself through its ISO 9001:2000 certification, a commitment to quality, personalized support, and a network of offices in San Diego, San Francisco, Boston, and China that enable broad client coverage. The overall goal is to help clients ensure their operations and facilities comply with industry regulations and operate reliably and safely.
Company Size
51-200
Company Stage
N/A
Total Funding
N/A
Headquarters
San Diego, California
Founded
1998
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Simplify's Take
What believers are saying
- Validation.org added FDA 483 response, warning-letter, and consent-decree remediation services in 2026.
- Recent postings show active hiring for CQV and ELN validation projects in Los Angeles and Korea.
- LinkedIn and validation.org highlight AI, GxP training, and automation messaging, broadening deal flow.
What critics are saying
- ZipRecruiter shows contract CQV roles, signaling project churn and utilization risk in 2026.
- The business depends on regulated manufacturing demand and client audits, tightening budgets quickly.
- An existential risk hits if FDA compliance work shifts in-house or to larger consultancies.
What makes VTI Life Sciences unique
- Founded 1996, VTI offers CQV, CSV, automation, and FDA 483 response services.
- Validation.org lists 27 years of cGMP, GLP, and computerized systems validation experience.
- Offices span San Diego, Boston, North Carolina, Canada, China, Singapore, and Thailand.
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Benefits
Remote Work Options
401(k) Company Match
Professional Development Budget
Company News
Using this methodology, Ventana Research, Inc. evaluated vendor submissions in seven categories: five relevant to the product experience - Adaptability, Capability, Manageability, Reliability and Usability - and two related to the customer experience - TCO/ROI and vendor Validation.