Asepsis, Biotech and Pharmaceutical, Computer Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Collection, Data Processing, Documentation, Drug Manufacturing, Environmental Monitoring, Healthcare, Interviewing Skills, Investigative Reports, Leadership, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Microsoft Excel, Microsoft Outlook, On Site Support, Operational Support, Problem Solving Skills, Project/Program Management, Quality Management, Reporting Skills, Root Cause Analysis, Structured Analysis, Technical Writing, Writing Skills
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 ethical standards for the following position:
- Investigation & CAPA Specialist
Position Summary
We are seeking an experienced Investigation and CAPA Specialist to provide on-site support for deviation investigations, root cause analysis, and CAPA development within a regulated aseptic manufacturing environment.
The selected candidate will support end-to-end investigations from a manufacturing and process perspective, including process review, data collection, personnel interviews, and development of investigation reports and recommended corrective and preventive actions for Quality approval.
This role requires strong investigation execution skills, technical writing capabilities, and the ability to work cross-functionally with Manufacturing, Engineering, Training, and Quality teams.
Key Responsibilities
- Lead and support manufacturing-driven investigations from initiation through completion, in alignment with site procedures and cGMP expectations
- Perform detailed reviews of manufacturing processes, batch records, environmental and process data to support root cause determination
- Independently lead failure investigations using structured root cause analysis tools and recommend systemic corrective and preventive actions
- Author clear, concise investigation documentation, including root cause analysis and recommended CAPAs, for Quality review and approval
- Manage and execute assigned corrective and preventive actions within the site quality management system (CQMS)
- Support assignment, tracking, and follow-up of investigation-related actions and non-conformances
- Conduct interviews with manufacturing, operations, and support personnel
- Support investigation-related activities involving environmental or process monitoring data, as applicable
- Participate in cross-functional meetings related to investigations and CAPAs, including review boards, as required
- Support updates to procedures or work instructions related to investigation outcomes, as needed
- Interface effectively with Manufacturing, Engineering, Training, and Quality functions
- Ensure investigation and CAPA documentation is accurate, complete, and inspection-ready
- Maintain on-site presence in manufacturing and controlled areas as required
Preferred Experience
- Familiarity with gowning practices and contamination control principles
- Experience working with electronic quality management systems (e.g., CQMS)
Required Qualifications
- Bachelor’s degree in Engineering, Science, or a related technical discipline (or equivalent industry experience)
- Minimum of 5 years of experience supporting investigations in pharmaceutical or biotechnology manufacturing
- Demonstrated experience leading manufacturing or process investigations and authoring investigation reports
- Strong technical writing skills and ability to clearly document complex investigations
- Understanding of aseptic manufacturing processes and cGMP requirements
- Experience gathering data, conducting interviews, and supporting root cause analysis
- Ability to manage multiple active investigations concurrently
- Strong critical thinking and problem-solving skills
- Proficiency with standard computer applications (e.g., MS Outlook, Excel)
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.
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