MV01-031126 Lead Deviation Investigator

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Lead Deviation Investigator

Description:

The Lead Deviation Investigator is responsible for overseeing, conducting, and documenting investigations related to deviations, nonconformances, and quality events. This role ensures timely, thorough, and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). The role requires strong analytical skills, technical writing expertise, and the ability to collaborate across cross functional teams.

Key Responsibilities:

• Lead end-to-end investigations for deviations and nonconformance events, including data gathering, documentation review, and personnel interviews.
• Perform structured root cause analysis using methodologies such as 5 Whys, Fishbone, Fault Tree, and Causal Factor analysis.
• Develop and implement effective Corrective and Preventive Actions (CAPA) to address root causes and prevent recurrence.
• Prepare clear, accurate, and compliant investigation reports that meet GMP and regulatory requirements.
• Collaborate cross-functionally with Operations, Quality Assurance, Engineering, and Maintenance to resolve quality events and drive continuous improvement.
• Ensure investigations, CAPAs, and documentation are completed within required timelines and quality standards.

Skills:

• Strong understanding of GMP, GDP, and regulatory expectations.
• Expertise in root cause analysis tools and structured problem solving.
• Proficiency in CAPA development, implementation, and effectiveness evaluation.
• Excellent technical writing and documentation skills.
• Ability to interpret data, trends, and process performance indicators.
• Strong communication, facilitation, and interpersonal skills.
• Ability to manage multiple investigations simultaneously and prioritize effectively.

Preferred Qualifications:

• Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
• Familiarity with electronic quality systems (TrackWise, Veeva, etc.).
• Background in engineering, life sciences, or a related technical field.
• Experience leading Deviation Investigations.
• Available to work extra hours and possibly weekends
• BS in Sciences and experience in Dry Product Manufacturing / Oral Solid Dosage (OSD)
• Minimum of five (5) years of relevant experience preferred; candidates with fewer years but strong and demonstrable experience will also be considered.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.