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.

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

Position Summary

The Director of Engineering and Facilities is an integral part of the Civica site leadership team in establishing and building the overall site organization and infrastructure.  Responsibilities of the position include leading, directing and coordinating engineering, maintenance, automation and technical operations at the Civica manufacturing site that result in the reliable supply of quality essential medicines. This includes assisting in development of strategic vision and long-range planning for the site, as well as a focus on execution and team building to ensure compliance with Civica cultural tenets and sustainable and cost-effective manufacturing operations for the site.  Champions a safe working environment, strong quality culture, and compliance to established policies, procedures, and guidelines for the engineering department and the overall site.  

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Provide overall engineering, facilities and technical leadership to ensure that the mission, core values and culture of the Company are put into practice at the site.
• Lead the engineering and facilities team in oversight of facility and equipment process development and maintenance.
• Effectively work with local partners in various required broader facilities site activities, projects, oversight, and ongoing operations.
• Implement site engineering/maintenance/automation/technical services strategy in alignment with site, company plans and member needs.
• Create and execute department policies and programs to maximize capacity/utilization and ensure quality supply and low costs.
• Develop standard operating procedures for the department and site, including standard work, documentation, and tools to increase operation efficiency and risk management.
• Provide vision and strategic input toward overall success of the department, site and the company.
• Lead site organization in establishing teamwork and morale.
• Establish performance and development plans for department staff, as standardized by the site and company, consistent with a culture of individual and team accountability and high performance.
• Ensure that quality, regulatory compliance, and safety are key elements of the department culture.
• Assure interface and sound relationships with regulatory agencies like FDA, DEA, OSHA, EPA, etc. and the Site Leadership Team.
• Carry out leadership and management responsibilities in accordance with department, site, and Civica’s corporate policies, as well as applicable laws for the industry.
• Effectively manage through clear, direct, and respectful communications within department, site, and through interactions at the corporate level.
• Establish departmental performance goals and objectives.
• Interact with other functional disciplines throughout the site and company, as necessary, in achieving both site and company objectives.
• Appropriately and successfully represent Civica in local and state interactions, as necessary.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Must have a college degree in a relevant discipline, such as engineering and/or the sciences, and at least 15 years of experience in facilities engineering management in a pharmaceutical manufacturing environment, in aseptic product manufacturing and/or injectable drugs.
• Deep technical knowledge in the facilities, utilities and equipment for sterile fill facilities.
• Exceptional leadership abilities to inspire and motivate others to perform well, and accept feedback from others; delegate work assignments, give authority to work independently, set expectations, and monitor delegated activities.
• Ability to involve staff in planning, decision-making, facilitating, and process improvement; be available to staff; provide regular performance feedback; and develop subordinates’ skills and encourage growth.
• Experience in working with cross-functional teams.
• Comprehensive knowledge of industry and industry-related trends and forecasts, including direct and comprehensive familiarity with FDA compliance requirements, such as cGMPs, cGLPs, cGDPs, DSCSA, etc.
• Ability to identify and resolve problems in a timely manner, as well as skillfully gather and analyze information utilizing appropriate root cause analysis, FMEA, and other tools.
• Demonstrate effective project management skills, including use of appropriate tools and ongoing oversight.
• Speak clearly and persuasively in positive or negative situations, demonstrate group presentation skills, and conduct productive meetings (documented action plans, identified responsibilities, and timing).
• Willingness to explore ways to improve and promote quality and regulatory compliance; demonstrate accuracy and thoroughness; and maintain compliance with legal and regulatory requirements.
• Develop, implement, promote, and enforce site environmental, health, safety and security procedures for all personnel, equipment, materials, and activities at the site.
• Ability to multi-task and work in a fast-paced operations environment.
• Thorough understanding and experience in developing and implementing state-of-the-art technical strategies through knowledge of industry practices, company history, culture, identity, and goals.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Pursues training and development opportunities; Strives to continuously improve and build knowledge and skills.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments; Maintains confidentiality.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings.
• Written Communication - Writes clearly and informatively; Able to read and interpret written information.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust.
• Adaptability - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Monitors transition and evaluates results; Able to deal with frequent change, delays, or unexpected events.
• Delegation - Delegates work assignments; Gives authority to work independently; Sets expectations and monitors delegated activities.
• Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff and others; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Improves processes, products and services.; Continually works to improve supervisory skills.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals; Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Diversity - Demonstrates knowledge of EEOC policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Supports affirmative action and respects diversity; Builds a diverse workforce.
• Ethics - Treats people with respect; Works with integrity and ethically; Upholds organizational values.
• Strategic Thinking - Understands organization's strengths and weaknesses; Analyzes market and competition; Adapts strategy to changing conditions.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; Looks for ways to improve and promote quality; Monitors own work to ensure quality.
• Safety and Security - Observes safety, environmental and security procedures; Reports potentially unsafe conditions.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent.
• Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and other computer software, as required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee 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 duties of this position, the employee is regularly required to talk 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.  Furthermore, the employee must be capable of successfully passing aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus.  The noise level in the work environment is usually low to moderate.