Sr. Validation Engineer

Sr. Validation Engineer

Location: San Diego, CA

Salary: $55/hour

Start Date: Right Away

Shift: 8:00am-5:00pm

Keywords: #EngineeringJobs #ValidationEngineer #SanDiegoJobs

Benefits:

• Medical/Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision
• 401k
• On the job training / cross-training
• Life Insurance, disability insurance, and voluntary life insurance for family members available
• Accident and critical illness insurance optional
• Scheduled performance reviews
• Referral program

Job Description

The Validation Engineer is responsible for the execution and management of qualification/validation activities for process, cleaning, equipment, computer software or facilities on site. The engineer prepares and executes validation/qualification and re-qualification activities as necessary for new and modified process, cleaning, equipment, computer software or facilities so that the qualification status is maintained at all times. Assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.

Responsibilities

• 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/support the development of process, cleaning, equipment, computer software or facilities qualification 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) - 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/validation document listing for all qualified/validated process, cleaning, equipment, computer software or facilities on site.
• Ensure all qualification documentation is maintained up to date at all times.
• 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.
• 50/50 on process and equipment validation

Education and Experience

• Bachelor’s in Mechanical or Chemical Engineering, Science, or related field.
• At least 5-7 years experience in pharmaceutical/biotech operations.
• Minimum 5 years of direct/hands on experience with validation of process, cleaning, equipment, computer software or facilities with thorough working knowledge production unit operations and validation principles.
• 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.
• Design experience or owners experience in manufacturing processes required.
• Design experience or owners experience in utility systems including purified water, WFI, CIP, SIP, compressed air and waste treatment desired.
• Experience with design transfer.
• Should have experience with writing validation protocols and design validation studies and executing protocols / studies, analyzing data and writing validation reports.

Skills and Knowledge

• 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.
• Proficient in MS Word, Excel, and Project.
• Good writing and communication skills.
• Team player

If you are interested in this role, please apply via the apply now link provided.