Senior Engineer, Corporate Quality Assurance Validation

The Senior Engineer Corporate Quality Assurance Validation is an individual contributor within the Corporate Quality Assurance organization responsible for ensuring company-wide validation and qualification activities comply with cGMP (21 CFR Parts 210/211) 21 CFR Part 11 and applicable USP and ICH guidelines. This role supports validation of equipment processes computerized systems and analytical methods including instrument qualification method validation and method transfer while driving risk-based efficient validation lifecycle practices in an FDA-regulated environment.

The position requires strong expertise in analytical validation and data integrity with a focus on compliance quality and continuous improvement. The role partners across Quva sites to standardize and sustain validation methodologies ensuring consistency and regulatory alignment. Working cross-functionally with IT Quality Operations Engineering Facilities and Pharmacy Services the Senior Engineer ensures validation activities are scientifically sound compliant and effectively executed to support both projects and routine operations.

The ideal candidate has extensive experience in pharmaceutical manufacturing deep knowledge of analytical validation and a strong understanding of global regulatory expectations contributing to Quvas mission of expanding access to high-quality affordable medications.

Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety efficacy and quality providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

This is an on-site role Monday - Friday at our Bloomsbury New Jersey location.

What the Senior Engineer Corporate Quality Assurance - Validation Does Each Day:

• Ensures analytical methods are validated and transferred in compliance with ICH (e.g. Q2) USP and regulatory expectations
• Oversees and enforces data integrity controls in accordance with FDA requirements and ALCOA principles
• Provides QA oversight of laboratory and validation activities to ensure compliance with internal procedures and regulatory standards
• Reviews and approves validation deliverables (e.g. IQ/OQ/PQ/PV protocols reports risk assessments lifecycle documents change controls and Part 11 assessments) ensuring activities are appropriately designed executed and documented
• Authors and executes validation deliverables as needed to support business priorities
• Serves as QA representative during audits and regulatory inspections related to validation and laboratory systems
• Partners cross-functionally (QC Validation IT Manufacturing) to ensure validation lifecycle compliance
• Assesses validation impact within change control processes
• Supports investigations involving validation deviations or data integrity issues
• Drives continuous improvement of validation and quality systems
• Provides technical leadership and mentor junior staff and cross-functional teams

Our Most Successful Senior Engineer Corporate QA - Validation:

• Strong attention to detail and critical thinking skills
• Independent judgment and decision-making
• Strong written and verbal communication skills
• Ability to influence cross-functional teams without direct authority
• Risk-based thinking and problem-solving
• High level of integrity and accountability

Minimum Requirements for this Role:

• Bachelors degree in Engineering Life Sciences Chemistry or related field (advanced degree preferred)
• 58 years of experience in Quality Assurance Validation or related roles within the pharmaceutical or biotech industry
• Working knowledge of USP and ICH regulatory requirements
  • Experience reviewing and approving validation documentation
  • Familiarity with GMP (Good Manufacturing Practices) environments
  • Strong background in laboratory validation including:
• 18 years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Experience in Validation roles rather than execution-focused Quality Assurance roles
• Exposure to regulatory inspections (e.g. FDA audits)
• Knowledge of data integrity principles (e.g. ALCOA)
• Experience with electronic systems used in laboratory and validation environments (e.g. LIMS)

Benefits of Working at Quva:

• Set full-time consistent work schedule
• Comprehensive health and wellness benefits including medical dental and vision
• 401k retirement program with company match
• 17paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National industry-leading high growth company with future career advancement opportunities
• The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience skills training education certifications geographic location and market conditions
• Range: $135048 - $177695 Annually
• This role is also eligible for an annual incentive bonus subject to program terms and guidelines

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of Pharmas multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners with health systems to aggregate normalize and analyze large amounts of complex data across their sites of care and through proprietary machine learning transforms data into actionable insights supporting revenue optimization script capture inventory management drug shortage control and more. Quvas overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quvas Equal Opportunity Policy prohibits harassment or discrimination due to age ancestry color disability gender gender expression gender identity genetic information marital status medical condition military or veteran status national origin race religious creed sex (including pregnancy childbirth breastfeeding and any related medical conditions) sexual orientation and any other characteristic or classification protected by applicable laws. All employment with Quva is at will.

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Required Experience:

Senior IC