6485 - Project Engineer / Project Engineer 2

United States·Indianapolismid

EngineeringProject Engineer

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Quick Summary

Key Responsibilities

Develop and optimize VHP (Vaporized Hydrogen Peroxide) decontamination cycles for pharmaceutical manufacturing isolators. Develop Biological Indicator (BI) placement strategies,

Requirements Summary

Qualification protocols and reports Risk assessments SOPs VHP cycle development documentation Supporting validation and lifecycle documentation Provide technical guidance on VHP implementation,

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

→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

~2 min read

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.

*Verista is an equal opportunity employer.

National (US) Range

$85,470—$127,144 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