Associate Validation Engineer (270)
Civica

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 and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Position Summary

The Associate Validation Engineer will assist in the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes in support of projects, operations, and quality objectives. Working closely with system owners and related stakeholders (Operations, Engineering, Laboratories, IT, and Quality Assurance). This role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, reviewing, and executing related CQV documentation as well as related documents for the role (e.g., procedures and change control records).

The Petersburg site serves as Civica's new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Essential Duties and Responsibilities:

• Execute validation activity as defined by approved protocols and test plans. Where applicable, this includes operating equipment or executing the process which is being validated.
• Perform relevant testing or evaluation during validation and document the results into validation protocols.
• Create detailed and meticulous records during validation activity meeting GMP standards.
• Investigate and troubleshoot validation problems as they occur.
• Complete validation activity in coordination with other related groups (e.g., manufacturing, engineering, or testing labs).
• Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties.
• Support all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
• Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions.
• Support the development of Standard Operating Procedures for new processes and equipment.

Basic Qualifications and Capabilities:

• A minimum of an associate's degree in a relevant technical field is required (e.g., engineering, biology, chemistry, etc.). Bachelor's degree is a plus.
• 2+ year's progressive experience in a manufacturing, quality, technical, or validation role at a pharmaceutical manufacturing / distribution facility, with at least 2 years of validation activity.
• Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
• Ability to lead, take ownership, and follow through on assigned projects.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Exposure to a process improvement environment, including change management and participating in Lean/Six Sigma project teams.
• Ability to work autonomously within established guidelines, procedures, and practices.

Preferred Qualifications:

• Experience with regulatory inspections is preferred.
• Experience in a sterile fill-finish facility.
• Start-up experience preferred.
• Knowledge or experience with technical documentation such as P&ID, wiring diagrams, and schematics preferred.
• Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.

Physical Demands and Work Environment:

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

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