Validation Engineer - Indianapolis
PACIV, an international control systems integration and regulatory compliance engineering firm, servicing Bio-Pharmaceutical, Medical Device, F&B and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) employee for our USA office (Indianapolis).
Job Description:
The Validation Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets within our client's Biotechnology and Pharmaceutical sites.
This support service will be performed working within the client's validation, project management, quality and/or automation department team(s).
Position Responsibilities/Essential Functions Execute System Lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) planning documents through System Retirement Actively participate among cross-functional teams and support project initiatives to ensure projects are delivered on time and to required quality standards Support execution of large product launch/release, small capital projects, and process improvement changes related to the manufacturing and/or laboratory systems within the client site Requirements Bachelor's degree and/or Master's degree in Engineering or Technical discipline required 1 - 3 years validation experience in the Pharmaceutical Industry Comfortable with 24/7 manufacturing environment Works well with others, within a team and takes accountability Can handle a high-pressure, high-stress work environment Result driven and self-motivated Strong interpersonal and communication skills (verbal and presentation) Organized, with strong computer literacy such as MS Word, Project, Excel, etc.
Desired Hard Skill Sets (via Internships/Co-Ops):
Familiarity with Validation principles and executable deliverables (i.
e.
Requirements, Design, Testing, Reports, etc.
) CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Record and Signatures Project Management experience with the ability to lead and drive projects to completion autonomously Other RequirementsLocation:
IndianapolisTravel:
Up to 20% of the time to various suppliers, collaborators, and client sites outside of IndianapolisCompensation:
Competitive Salary and Benefits Package, which includes:
Paid Time Off (PTO) for vacation, sick, and company holidaysPTO is earned on an accrual basis throughout the calendar year.
Health InsurancePACIV pays 90% of the premium for the health insurance plan.
Monthly contributions made by PACIV and are distributed through an HSA (Health Savings Account) $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the employee's cost.
401(k) Retirement Plan with company match Project Performance Bonuses (for qualified projects and employees) Recommended Skills Automation Biotechnology Business Process Improvement Communication Computer Literacy Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
Job Description:
The Validation Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets within our client's Biotechnology and Pharmaceutical sites.
This support service will be performed working within the client's validation, project management, quality and/or automation department team(s).
Position Responsibilities/Essential Functions Execute System Lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) planning documents through System Retirement Actively participate among cross-functional teams and support project initiatives to ensure projects are delivered on time and to required quality standards Support execution of large product launch/release, small capital projects, and process improvement changes related to the manufacturing and/or laboratory systems within the client site Requirements Bachelor's degree and/or Master's degree in Engineering or Technical discipline required 1 - 3 years validation experience in the Pharmaceutical Industry Comfortable with 24/7 manufacturing environment Works well with others, within a team and takes accountability Can handle a high-pressure, high-stress work environment Result driven and self-motivated Strong interpersonal and communication skills (verbal and presentation) Organized, with strong computer literacy such as MS Word, Project, Excel, etc.
Desired Hard Skill Sets (via Internships/Co-Ops):
Familiarity with Validation principles and executable deliverables (i.
e.
Requirements, Design, Testing, Reports, etc.
) CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Record and Signatures Project Management experience with the ability to lead and drive projects to completion autonomously Other RequirementsLocation:
IndianapolisTravel:
Up to 20% of the time to various suppliers, collaborators, and client sites outside of IndianapolisCompensation:
Competitive Salary and Benefits Package, which includes:
Paid Time Off (PTO) for vacation, sick, and company holidaysPTO is earned on an accrual basis throughout the calendar year.
Health InsurancePACIV pays 90% of the premium for the health insurance plan.
Monthly contributions made by PACIV and are distributed through an HSA (Health Savings Account) $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the employee's cost.
401(k) Retirement Plan with company match Project Performance Bonuses (for qualified projects and employees) Recommended Skills Automation Biotechnology Business Process Improvement Communication Computer Literacy Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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