Project Engineer - 3230SS

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements

Project Engineer Responsibilities:

This position will need to be on-site Indianapolis.

• Support site engineers with process improvements in managing changes to currently validated equipment in a highly automated environment
• Deep understanding of equipment reliability practices and change control as it relates
• Leading and participating in pFMEA sessions with cross-functional teams
• Develop and execute change management packages to support site-based changes to equipment for process improvements
• Collaborate with cross-functional teams (i.e. Operations/Engineering/Quality)
• Leading the CQV (Commissioning, Qualification and Verification) processes for protocol development and execution.
• Leading internal and/or client management activities for assigned projects:

• Providing frequent/clear/concise project updates to internal/external customers (bi-monthly minimum).
• Utilizing troubleshooting/problem solving skills to drive solutions to equipment/process issues, including FMEA and root cause analysis methodology.
• Providing technical expertise on equipment/processes/facilities/utilities in manufacturing, laboratory, and packaging areas.
• Developing, writing, and executing engineering studies.
• Developing SOPs/Guidance Documents for project equipment and processes which are highly complex and require advanced engineering to develop.
• Maintaining, updating, and communicating project status via dashboards or other customer preferred method.
• Executing projects to internal or customer standards, while also making recommendations to update standards to meet best practices.

You will have:

• This position requires a minimum of a Bachelor’s degree in an Engineering or Scientific degree
• Capital project management in fast-paced, highly regulated industries
• CQV Validation and Engineering experience
• Industrial/Manufacturing engineering experience involving compliance, procedures, and process improvements in highly regulated industry involving GMP, FDA, OSHA, and Change Control
• Experience with FMEA and other risk assessment tools

Desired Skills:

• 3 - 5 years of experience Project Engineering in an FDA regulated environment.
• Manufacturing, equipment efficiency experience.

• Able to drive process improvements on production lines
• Manage schedules and costs
• Lead cross-functional meetings

If you are qualified, have leadership potential and a willingness to learn, Verista could be the right career choice for you!

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical benefits.
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• Leadership development training, career planning, and tuition reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Maternity, Parental Leave and Bereavement

Verista is a leading business, technology and compliance company that enables