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

Description 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 Project Engineer Responsibilities: Project Engineering & Technical Leadership 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. Equipment & Automation Support 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. Validation & CQV Activities 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. Change Management & Compliance 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: Required 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. Preferred 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 Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. For more information about our company, please visit us at Verista.com

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