Sr Validation Engineer
San Diego, CA
Administrative and Corporate Functions – Facilities /
Full Time /
On-site
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Sr. Validation Engineer is responsible for planning, development, project management, and execution of life cycle engineering and validation lifecycle documentation elements of engineering and validation lifecycle design, commissioning, maintenance, qualification, and the interfaces with quality system lifecycle compliance requirements.
The Sr. Validation Engineer is responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests. In addition, the role is responsible for all tasks related to coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.
The Sr. Validation Engineer is responsible for data retrieval, compilation, verification, and comparative analysis from a variety of paper and electronic system formats. This will include authoring of studies, protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for new facility and equipment projects and re-qualifications.
Responsibilities
- Qualification/Validation project and protocol documentation development/authoring, field execution, data entry/compilation, and summary report development/approval
- Engineering Study/Protocol authoring; validation support of quality event processes (CC; CAPA; Deviation; Audit Responses)
- Other activities associated with equipment induction and use
Qualifications
- Bachelor’s degree in Engineering, or related scientific field.
- Five (5) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role.
- Five (5) years of experience with: GMP and 21CFR Part 11 compliance requirements; Laboratory systems with computer controlled functions and process validation; Mechanical equipment engineering and software functional testing; Applying advanced mathematical concepts such as exponents, algorithms, quadratic equations, and permutations; Applying mathematical operations to frequency distribution, variance analysis, and determination of reliability and validity; Regulatory guidance documents; Generating concise procedures, protocols, and summary reports; Applying sound validation principles; temperature mapping; and Equipment control software.
- Demonstrated ability to write Protocols, Change Controls, Deviations/CAPAs, SOPs, etc. with minimal outside input.
- Demonstrated ability in Project Management dynamics and techniques, ability to contribute to project management efforts with schedule logistics, projections, and resource analysis.
- Ability to support internal and external audits.
- Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
- Microsoft Office (Word, Excel, PowerPoint, Project, Teams), AutoCAD, CMMS Systems.
- Lifting and carrying up to 25 lbs.
- GMP equipment, utilities equipment ,temperature mapping instrumentation, computer systems.
$120,000 - $150,000 a year
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
