Validation Engineer II - GMP Validation & CAPA Lead

E2i Inc; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

PTO & holidays

Volunteer time off

Health insurance

Simple IRA with company match

Financial counseling

Education reimbursements

Job summary

E2i Inc. is seeking a lead investigator to uncover root causes for assigned deviations in a pharmaceutical client environment in Indianapolis, IN. The role involves interviewing operators, engineers, and managers, then developing CAPAs to prevent recurrence.

You will document investigations in Trackwise and coordinate with leadership for approvals. The position requires a Bachelor’s degree in engineering and 2–5 years of relevant experience, with a focus on data analysis, technical writing, and

Qualifications

• Bachelor’s degree in engineering or related field.
• 2–5 years of relevant work experience.
• Basic data analytics skills.
• Technical writing skills.
• Ability to read Electrical diagrams and P&IDs.
• Pharmaceutical manufacturing experience is a plus.

Responsibilities

• Build good relationships with customers.
• Perform field verifications of systems and related components.
• Maintain a minimum of 80% billable with leadership and sales support.
• Execute validation protocols per SOPs and ensure acceptance criteria are met.
• Organize and present qualification data, results and reports in validation files and manuals.
• Provide system support for manufacturing needs (PLC, HMI, DCS, SCADA).

Skills

Data analysis

Technical writing

Reading electrical diagrams

Reading P&IDs

Customer relationships

Education

Bachelor’s degree in Engineering

Tools

Trackwise

Job description

E2i Inc. is seeking a lead investigator to uncover root causes for assigned deviations in a pharmaceutical client environment in Indianapolis, IN. The role involves interviewing operators, engineers, and managers, then developing CAPAs to prevent recurrence.

You will document investigations in Trackwise and coordinate with leadership for approvals. The position requires a Bachelor’s degree in engineering and 2–5 years of relevant experience, with a focus on data analysis, technical writing, and