Validation Engineer - Insulin
Company: Civica RX
Posted on: November 17, 2023
The validation engineer will be responsible for leading the
commissioning, qualification, and validation (CQV) for a newly
announced facility expansion for biologics 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. 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, review, and execution of
related CQV documentation as well as related documents for the role
(e.g., procedures and change control records). Serves as subject
matter expert for CQV activities.
Essential Duties and Responsibilities:
- We are seeking a highly motivated Validation Engineer who is
interested in joining our fast-paced, dynamic start-up environment.
In this dynamic role you will provide validation expertise to help
us establish our Petersburg, VA facility, specifically the
Affordable Insulin program.
- You must have a willingness to perform "hands-on" work in a
dynamic, team-oriented work setting. Incumbent provides technical
expertise on CQV and ensure compliance to relevant
- Responsible for CQV activity, including all phases:
requirements, validation planning, protocol generation, test
execution, configuration documentation, and system
- Executes validation activity in a timely manner, planning and
proactively pursuing details to ensure project completion without
- Interpersonal skills to manage interactions and achieve results
across a range of functions within the site. May also extend to
external communication with system vendors.
Basic Qualifications and Capabilities:
- Bachelor's degree in engineering or relevant sciences and 7+
years of CQV experience.
- 5 years' experience with sterile injectables, combo-devices, or
- Start-up experience preferred.
- Advanced degrees or certification relevant to the role is a
- Ability to think strategically and tactically
- 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.
Keywords: Civica RX, Richmond , Validation Engineer - Insulin, Engineering , Petersburg, Virginia
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