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Title: Validation Engineer
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Validation Engineer
Compensation, Benefits, and Employment Type
- Duration – Contract – 12 months+
- Pay rate: 45-50/hr.
- Job Location: San Diego, CA
- Job# bh11969
- The Validation Engineer is responsible for the execution and management of validation activities for process, cleaning, equipment, computer software or facilities on site.
- The engineer prepares and executes validation/qualification and re-qualification activities for new and modified process, cleaning, equipment, computer software or facilities so that the qualification status of site is always maintained.
- The engineer also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.
- Ensure all company and Site Validation policies and procedures are adhered to.
- Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.
- Ensure all work undertaken is reflected accurately in up-to-date Validation / project information files.
- Lead installation and all qualification activities for Purified Water (PW), Clean In Place (CIP) and equipment cleaning systems.
- Lead all validation activities for new and/or changes to labels applied to all Manufacturing products to include expertise with HF RFID systems and tags. These activities extend to adhesive and ribbon/ink changes as well.
- Lead/support the development of process, cleaning, equipment, computer software or facilities protocols and ensures they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers, internal and external project personnel to ensure successful qualification execution).
- Seek and retain approval for qualification protocols from site User groups (who approve documents from a user group operations perspective) and Quality (who approve documents from a regulatory compliance standpoint).
- Lead the execution of qualification protocols on process, cleaning, equipment, computer software or facilities as necessary.
- Ensure the maintenance of a qualification document listing for all qualified equipment on site.
- Ensure all qualification documentation is always maintained up to date.
- Provide expert guidance for the resolution of technical issues arising during the execution of qualification activities.
- Perform any other activities as directed by the Validation Manager.
Required Skills and Abilities:
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
• Technical expertise in biotech unit operations, ability to handle multiple projects at one time
• Strong technical expertise all aspects of PW, CIP and equipment cleaning systems and processes
• Strong expertise in leading validation activities for labeling and HF RFID systems as well as label ribbon/ink label validation activities
• Working knowledge of processes in fermentation, purification and/or formulation required
• Strong leadership, organizational planning, and project management skills
• Excellent interpersonal effectiveness and communication skills (written and oral)
• Ability to work with a cross functional team to achieve expected results
• Direct hands-on experience with validation of process, cleaning, equipment, computer software or facilities
- Proficient in MS Word, Excel, and Project
Occupational Demands:
- Ability to lift 20-30 lbs. and stand for an extended period of time.
Education:
- Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.
- 4 years of relevant validation experience can be substituted in lieu of Bachelor’s Degree
Years of Experience:
- Minimum 5+ years of relevant validation experience in regulated industry with a Bachelor’s Degree in Engineering or Science discipline; or
High School Diploma with 9+ years of relevant validation experience
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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