6395 - Project Engineer (Radiopharmacy Equipment & Automation) / Project Engineer 2

United States·Noblesvillemid

EngineeringProject Engineer

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Quick Summary

Key Responsibilities

Project Engineering & Technical Leadership Serve as the primary liaison between operations, validation, engineering, automation, and vendor teams. Identify equipment, process,

Technical Tools

EngineeringProject Engineer

Description

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

Responsibilities

~1 min read

Serve as the primary liaison between operations, validation, engineering, automation, and vendor teams.
Identify equipment, process, and automation issues requiring investigation and remediation.
Translate operational and technical challenges into actionable requirements for automation engineers and contractors.
Coordinate project activities, track action items, and ensure timely resolution of technical issues.
Support project schedules, budgets, resource planning, and execution activities.
Lead equipment walkdowns and system assessments to identify gaps and improvement opportunities.
Escalate project risks, technical concerns, and schedule impacts to project stakeholders.

Troubleshoot manufacturing equipment and process systems used in radiopharmaceutical production.
Work closely with automation teams to diagnose and resolve PLC, HMI, SCADA, instrumentation, and control system issues.
Review and verify equipment functionality, operational performance, and system integration.
Support startup, commissioning, and operational readiness activities.
Coordinate vendors, contractors, and internal teams during equipment modifications and upgrades.
Review P&IDs, electrical schematics, functional specifications, and automation documentation.

Author, review, and execute commissioning, qualification, and validation documentation including:
- Commissioning Protocols
- IQ/OQ/PQ Protocols
- Validation Plans
- Traceability Matrices
- Summary Reports
- Risk Assessments
Ensure systems remain compliant with cGMP, GDP, and applicable regulatory requirements.
Support validation impact assessments related to equipment changes and process improvements.
Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities.
Support maintenance of the validated state throughout the equipment lifecycle.

Support change control activities related to equipment, automation, and manufacturing systems.
Collaborate with Quality and Engineering teams to assess validation impacts and implementation strategies.
Ensure compliance with FDA, cGMP, Data Integrity, and company quality standards.
Assist with deviation investigations, CAPAs, and corrective actions when required.

Requirements

~1 min read

Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
5+ years of experience supporting pharmaceutical, biotech, medical device, radiopharmaceutical, or highly regulated manufacturing environments.
Experience with commissioning, qualification, and validation of manufacturing equipment and systems.
Strong understanding of equipment lifecycle management and project execution.
Ability to read and interpret P&IDs, electrical drawings, and technical documentation.
Experience coordinating cross-functional teams and driving issue resolution.
Strong communication and stakeholder management skills.
Ability to work independently while managing multiple priorities.

Nice to Have

~2 min read

Experience in radiopharmaceutical, sterile manufacturing, aseptic processing, or nuclear medicine environments.
Experience supporting automation systems, PLCs, SCADA, HMIs, and process controls.
Knowledge of change control, deviations, CAPAs, and quality systems.
Experience supporting startup, commissioning, and facility expansion projects.
Familiarity with 21 CFR Part 11 and Data Integrity requirements.
Experience leading capital projects and equipment implementation efforts.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$80,465—$118,062 USD

Benefits

Why Choose Verista?

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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For more information about our company, please visit us at Verista.com