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Sr. Engineering Manager

Company: Civica Rx
Location: Petersburg
Posted on: August 6, 2022

Job Description:

About Civica
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.
Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica's innovative model is directly impacting patient care, click below to read a recent article from the New England Journal of Medicine.
https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189
Video Intro to Civica: https://vimeo.com/646267406
Job Purpose
In this critical role you will be responsible for all engineering project management, construction, and oversight of industry trade partners to deliver various capital projects at the Civica Petersburg facility. Will serve as the project manager for critical projects. Leads cross functional teams in the coordination and planning of projects from spending approval development to project closeout. Assuring that the engineering, construction, integrated commissioning, qualification and validation (CQV) are prepared for compliant commercial launch.
Major Accountabilities

Establishing safety culture and demonstrating safety by example
Determining project objectives, consistent with company priorities and policies
Leads project team including external contractors and coordinates their tasks through all project phases
Ensures necessary communication within the project team (meetings, reporting) and coordinates interfaces outside of the project team with stakeholders, subject matter experts and customers
Generates project execution plans including procurement strategies of outside services and materials. Leads vendor selection and contract negotiations
Develops project staffing plans with all stakeholders ensuring adequate internal participation for the project scope
Provides management direction in relation to project scope to ensure business need is met
Leads qualification tasks (plan, controlling and reporting) in coordination with the Engineering and Quality organizations according to valid SOP's and issues plant documentation according to site engineering requirements
Manages external relationships as it pertains to project scope including government authorities
Responsible for the management of capital projects greater than potentially $25 million
Provides technical expertise in SME area to include training junior level engineers or technical staff
Leading contract partner evaluation and selection process
Reviewing and approving cost estimates and establishing check and balance system
Establishes policies for major projects, interprets, executes, and recommends modifications to company-wide policies
Assist in verification procurement strategy, selection, and implementation
Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology
Education/Experience

10+ years related engineering experience with 7+ years managing capital projects required OR equivalent, including 4+ years' experience the pharmaceutical, biotech, or medical device operations
3+ years of leadership experience; with ability to lead and develop a high-performing team
Demonstrated knowledge of cGMPs and FDA requirements required
Demonstrated ability to lead and develop a high performing workforce
Previous operational readiness /project management/start-up experience
Minimum of a Bachelor of Science (BS) Degree in engineering or related discipline from a fully accredited institution.
Excellent oral and written communication skills, including presentations
Experience in a pharmaceutical/FDA-regulated manufacturing environment
Solid working knowledge of cGMP and facility/equipment validation requirements
Demonstrate commitment to values-based leadership and achieving objectives in a manner that is supportive of the client's values and leader behaviors
Ability to write clearly, concisely, and persuasively in a professional environment
Capacity to interact effectively with all levels of the organization

PI187947661

Keywords: Civica Rx, Richmond , Sr. Engineering Manager, Engineering , Petersburg, Virginia

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