Principal Engineer: Clean Utilities and HVAC (920)

BioSpace; Petersburg (VA); Vor Ort; USD 120.000 - 190.000; Vollzeit

Zusammenfassung

Civica is seeking a Principal Engineer: Utilities & HVAC for our new Petersburg, VA site. You will serve as the site SME for GMP HVAC, WFI, clean steam, process air, and nitrogen, guiding startup and day-to-day operations.

You will drive reliability, safety, and regulatory compliance across utilities and install a foundation for continuous improvement and capital projects. Bachelor’s in engineering with 6+ years of GMP utilities experience is required.

Qualifikationen

• Bachelor’s degree in engineering or relevant sciences.
• 6+ years of experience with GMP Utilities.
• 5 years’ experience with sterile injectables, combo-devices, or biologics.

Aufgaben

• SME with deep technical expertise in GMP HVAC and Utilities within pharmaceutical manufacturing.
• Ensure regulatory alignment with Civica standards and Industry requirements.
• Lead or participate in projects for HVAC, utilities, and related systems.
• Develop URs, specifications, test cases, and qualification documentation.
• Maintain KPI tracking for utility systems and ensure compliance.
• Provide operational guidance to maintenance and operations teams.
• Support inspections and CAPA activities as needed.
• Communicate with site customers and cross-functional teams.

Jobbeschreibung

About Civica

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages.

Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at www.civicarx.org

About Civica

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages.

Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at www.civicarx.org

Job Purpose

The Principal Engineer: Utilities & HVAC is the site Subject Matter Expert (SME) for GMP HVAC and Critical Utility systems (WFI, Clean Steam, Process Compressed Air, and Nitrogen) and the ancillary support systems. This role will have specific responsibility in the final project phase of construction at our new site and after project start-up for site day-to-day operation.

This role will be responsible for reliable and cost-effective operation of the site's HVAC, Utilities, and ancillary systems associated with our new manufacturing facility in Petersburg, VA. It will be essential to maintain all these systems in a state of compliance, safety, control, and fit for use. This role will also drive continuous improvement initiatives and local capital investment.

Major Accountabilities

SME with a deep technical expertise in all systems under his/her responsibility (GMP HVAC, GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, well versed with flow charts and process parameters, and awareness of industry trends.

Ensure the assigned processes are in alignment with the applicable regulatory Industry and Civica Standards.

Support risk assessment exercises using the different tools available (eg.FMEA) and participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals.

Lead or participate in projects/changes for all the systems under his/her responsibility including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.

Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state.

Monitor utility systems and maintain KPI's to assure that they are operating properly, in compliance with requirements.

Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters.

Implement efficient and effective maintenance and reliability techniques.

Apply problem solving skills by leading equipment failures, troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.

Provide customer consultation and notifications on issues that involve utilities areas. Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date.

Provide technical assistance as necessary to maintenance, and operations personnel.

Support internal and external inspections and investigations (including Quality and HSE).

Maintain efficient communications with appropriate site customer groups.

Proficiency with the DMS and CAPA systems.

Maintain, develop, and conduct operations training of utility systems.

Utilize statistical analysis tools to determine the process control, and capability for investigations.

Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership

Education/Experience

Bachelor’s degree in engineering or relevant sciences and 6+ years of experience with GMP Utilities

5 years’ experience with sterile injectables, combo-devices, or biologics.

Start-up Experience Preferred

Advanced degrees or certification relevant to the role is a plus.

Ability to think strategically and tactically (detail-oriented).

Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.

Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.