Validation Engineer IV Job in San Diego 92121, California US
position description
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Validation Engineer, Level IV to work for a leading San Diego biotechnology company.
Validation Engineer, Level IV
Summary:
The primary purpose of this position is to support, improve and grow the Validation Program. The position acts as a lead/project manager on large and/or complex projects, by performing CQ, IQ, OQ and PQ Validation studies. These activities include but are not limited to writing Validation Plans, Validation Protocols, Final Reports, Standard Operating Procedures, Equipment and Software Change Controls.
Essential Duties Responsibilities:
- Author, Execute, Review Data for Complex Validation Protocols including generation and approval of Final Reports, SOPs and Equipment/Software Change Controls.
- Document deviations, testing failures, investigations and corrective actions related to validation testing.
- Develop validation test plans for equipment, systems, procedures (cleaning, etc.), department policies as required.
- Mechanical system and drawing review; provide technical design input (capacities, sloping, process, etc.).
- When required, represent the Validation Manager as a delegate in meetings and for document approval.
- Lead and coordinate validation team(s) to perform tasks required to complete large scale projects (i.e. renovation/construction projects, new equipment skids)
- Use proper project management tools in implementing and tracking validation projects.
- Occasional travel may be required for Validation Activities and Factory Acceptance Testing.
- Support the Validation Manager, when required, in any regulatory inspections and audits.
- Perform other duties as directed by supervisor.
Education and Experience:
- Minimum 7 years of relevant pharmaceutical/biotech industry experience.
- BS degree in Science/Engineering or equivalent experience.
Knowledge, Skills, and Abilities:
- Understanding and practice of cGMPs.
- Software proficiency - basic word processing, spread sheet applications, CAD or other drawing programs and statistical programs.
- Computer Validation and GAMP principles.
- Ability to lead and coordinate validation teams.
- Ability to write validation SOPs, Protocols and Final Reports.
- Ability to manage multiple responsibilities with a high degree of self motivation.
- Ability to work both independently as well as team oriented.
- Ability to work in an organized and detail oriented fashion.
- Effective oral, written, and interpersonal communication skills.
- Experience with data acquisition set up, programming and calibration.
- Experience with CQ, IQ, OQ, PQ studies, Process, Cleaning and Computer Validation.
- Experience with validation of WFI systems, HVAC systems, SIP and CIP, Dry Heat Tunnels and Ovens, Autoclaves, Vial and Glassware Washers, Cleaning Validation, Aseptic Filling Operation Validation, and other utilities and pharmaceutical equipment validation.
- Provide subject matter expertise during inspections and regulatory audits.
- Incumbent may need DEA clearance in order to perform some validation studies.
Contact keith@biophaseinc.com if interested! Visit www.biophaseinc.com to view all our current openings!