Director, Engineering - Insulin
Company: Civica RX
Posted on: November 17, 2023
The Director Engineering will lead the Petersburg Insulin
program at Civica and is a member of the site leadership team at
Petersburg. Responsibilities of the position include leading,
directing and coordinating the Petersburg Insulin program including
the newly announced facility expansion that includes a dedicated
high-speed cartridge filling line, significant utilities upgrade,
dedicated formulation and processing suites, with Clean In Place
(CIP) and Sanitize In Place (SIP) capabilities. 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 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
- Lead the Petersburg Insulin program team and drive
accountability for deliverables in a matrix environment.
- Provide engineering and technical leadership and management to
ensure that the mission, core values and culture of the Company are
put into practice at the site.
- Lead site Insulin program team and provide oversight of
detailed facility and equipment design, construction, process
development/validation, and qualification.
- Implement site engineering/maintenance/technical services
strategy in alignment with site, company plans and member
- 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
- Establish project performance goals, milestones, and
- Interact with other functional disciplines throughout the site
and company, as necessary, in achieving both site and company
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 large, complex capital projects and engineering
management in a pharmaceutical manufacturing environment.
- Must have 10+ years of biologics biopharma experience with
aseptic product manufacturing and/or injectable drugs.
- 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 with leading cross-functional teams in
a matrix environment.
- 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,
- - - - - - - - - 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
- - - - - - - - - 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
- - - - - - - - - Develop, implement, promote, and enforce site
environmental, health, safety and security procedures for all
personnel, equipment, materials, and activities at the site.
- 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. -
Keywords: Civica RX, Richmond , Director, Engineering - Insulin, Engineering , Petersburg, Virginia
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