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5868 - Project Engineer / Risk Management (Pharma / Med Device)

5868 - Project Engineer / Risk Management (Pharma / Med Device)

VeristaIndianapolis, IN, US
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Project Engineer / Risk Management (Pharma / Med Device)

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

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

We are seeking a highly motivated Project Engineer with proven experience in risk management within the pharmaceutical or medical device industry. This role will be responsible for leading and supporting cross-functional projects that ensure product and process compliance while minimizing risks throughout the product lifecycle. Candidates with experience or familiarity in Turbo AC (Air Conditioning or Turbo Compressor) systems are highly desired.

Project Engineer Risk Management (Pharma / Med Device) Responsibilities :

  • Lead and support risk management activities (e.g., FMEA, Fault Tree Analysis, Risk Registers) throughout the product lifecycle
  • Coordinate with cross-functional teams (QA, Regulatory, Manufacturing, R&D) to ensure risk mitigation strategies are effectively implemented
  • Drive the development, execution, and documentation of engineering project plans, timelines, and deliverables
  • Analyze and interpret engineering specifications, user needs, and technical drawings to support risk assessments and product safety evaluations
  • Manage technical issues and provide solutions that align with project objectives and compliance standards
  • Prepare and deliver clear project updates, risk reports, and design documentation to stakeholders
  • Support product verification and validation (V&V) efforts, ensuring alignment with regulatory and industry standards
  • Contribute technical expertise, especially where Turbo AC systems are applicable in the design or manufacturing environment

    • Requirements :

  • Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field)
  • Minimum 35 years of experience in risk management within the pharmaceutical or medical device industry
  • Deep understanding of relevant FDA / EMA regulations
  • Strong project engineering and cross-functional collaboration skills
  • Excellent problem-solving and analytical skills
  • Experience or working knowledge of Turbo AC systems (e.g., turbo compressors, air conditioning systems in regulated environments)
  • Local resource (Indianapolis) is desired but remote is possibility for a candidate that is a solid fit

    • National (US) Range

    80,465 - $132,593 USD

    Benefits

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement
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    Project Engineer • Indianapolis, IN, US