Validation Engineer II

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 is a small systems integrator that has specialized in automation, validation, informatics, control panel design, and fabrication for the last 36 years. Our mantra is Quality People. Quality Results.At E2i, self-growth is at the basis of many decisions.

Working as a systems integrator, you will have the opportunity to diversify your talents within a variety of manufacturing industries (pharmaceutical, food & beverage, automotive, etc). E2i promotes personal and professional growth through the usage of our Team Member Investment Program and Promotion Plan; each fosters continued growth throughout your career with E2i. When it comes to team member feedback, they have made it clear when asked what do they like the most about E2i. It is our people. Every face has a name and every name has a story.

We are growing and have many opportunities available that might suit your interests.

Snapshot of Position:

• As a lead investigator, you are responsible for uncovering the root cause for your assigned deviations. This is done through interviews with those involved (operators, management, engineers, etc) and reviewing documentation/procedures and historian data. Once a root cause has been found, you work with management to develop CAPAs (corrective or preventative actions) to ensure the deviation does not occur again in the future. A report of the investigation is documented within Trackwise software and submitted for approval from leadership.
  

Location & Travel:

• Primary Location: At our Lebanon or downtown Indianapolis, IN pharmaceutical client with the possibility to support clients in other locations

What E2i Will Provide You:

• 20+ PTO Days, Holidays, Volunteer Time Off
• Comprehensive benefits package including health, dental, vision, life, and critical care insurance
• Simple IRA offering with company match and 1:1 financial counseling with a Certified Financial Planner
• Reimbursements for continuing education, professional memberships, and training

Your Role’s Responsibilities:

• Building good relationships with customers
• Performing field verifications of systems and related components
• Remaining a minimum of 80% billable with leadership and sales assistance
• Executing validation protocols per related SOPs and assure that acceptance criteria related to the protocols are met
• Organizing and presenting qualification data, results, documentation, and reports within the appropriate equipment/system validation files and system manuals
• May provide system support for manufacturing needs:
  • Supports PLC, HMI, DCS, and SCADA software for control systems and equipment (e.g. control panels, machines, processes, etc.)
  • Investigates and solves automation problems
    

What You Need for this Position:

• Bachelor’s degree in a related engineering field
• 2 - 5 Years of relevant work-related experience
• Basic data analytic skills
• Technical writing skills
• Ability to read Electrical diagrams and Piping and Instrumentation Diagrams (P&IDs)
  
• Pharmaceutical manufacturing experience a plus
• Familiarity with manufacturing/lab equipment operations
  

Want more information?