6485 - Project Engineer / Project Engineer 2

Verista, Inc.; Indianapolis (IN); On-site; USD 85,000 - 127,000; Full time

Benefits offered by this job

Life Insurance

Short-Term Disability Insurance

Long-Term Disability Insurance

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Verista, Inc. is seeking a Project Engineer to develop and optimize VHP decontamination cycles for pharmaceutical isolators. You will plan BI placements and worst-case challenge testing, execute cycles, and troubleshoot decontamination performance.

The role involves drafting PQ protocols, analyzing data, and maintaining validation documentation in a highly collaborative setting. You will work with Validation, Engineering, Manufacturing, and Quality teams to ensure compliance with cGMP and

Qualifications

• Hands-on experience with VHP cycle development and qualification for pharmaceutical isolators.
• Strong knowledge of aseptic processing and contamination control principles.
• Experience authoring and executing PQ protocols and final validation reports.
• Understanding GMP validation requirements in pharma/biotech manufacturing.
• Excellent technical writing skills and ability to draft protocols, reports and SOPs.
• Familiarity with regulatory expectations for VHP decontamination and isolator qualification.

Responsibilities

• Develop and optimize VHP decontamination cycles for pharmaceutical isolators.
• Plan BI placement strategies and worst-case challenge testing.
• Execute VHP cycles, troubleshoot performance and decontamination issues.
• Author and run PQ protocols; analyze data and prepare reports.
• Maintain validation documentation and lifecycle records.
• Collaborate with Validation, Engineering, Manufacturing, Quality and other teams.
• Ensure compliance with cGMP and applicable regulatory standards.

Skills

VHP cycle development

Aseptic processing

BI placement strategies

PQ protocols

GMP validation

Technical writing

Cross-functional collaboration

Regulatory knowledge

Job description

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

• Develop and optimize VHP (Vaporized Hydrogen Peroxide) decontamination cycles for pharmaceutical manufacturing isolators.
• Develop Biological Indicator (BI) placement strategies, including identification of worst-case locations and execution of challenge studies.
• Execute VHP development cycles and troubleshoot cycle performance, distribution, and decontamination issues.
• Author and execute Performance Qualification (PQ) protocols for isolator decontamination systems.
• Analyze cycle and validation data, perform technical assessments, and prepare final reports.
• Author, review, and revise validation documentation, including: Qualification protocols and reports Risk assessments SOPs VHP cycle development documentation Supporting validation and lifecycle documentation Provide technical guidance on VHP implementation, validation strategy, and lifecycle management.
• Ensure activities and documentation comply with cGMP requirements and applicable regulatory/industry standards.
• Collaborate with Validation, Engineering, Manufacturing, Quality, and other cross-functional stakeholders.

Requirements

• Demonstrated hands-on experience with VHP cycle development and qualification for pharmaceutical isolators.
• Strong knowledge of aseptic processing and contamination control principles.
• Experience developing and executing BI placement and worst-case challenge strategies.
• Experience authoring and executing PQ protocols and preparing final validation reports.
• Strong understanding of GMP validation requirements within pharmaceutical or biotechnology manufacturing.
• Experience troubleshooting VHP cycle development and performance issues.
• Strong technical writing skills with experience authoring protocols, reports, risk assessments, and SOPs.
• Knowledge of current regulatory expectations and industry best practices for VHP decontamination and isolator qualification.
• Strong analytical, problem-solving, and cross-functional communication skills.
• Experience supporting sterile/aseptic pharmaceutical manufacturing operations.
• Experience with VHP systems used in filling, packaging, or other aseptic manufacturing isolators.
• Familiarity with contamination control strategies and the qualification/lifecycle management of barrier systems.

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.

National (US) Range $85,470 — $127,144 USD

*Verista is an equal opportunity employer.

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