Validation Manager - Continental Search : Job Details

We want to make you aware of an exciting and challenging opportunity to be the Validation Manager for this manufacturer of biological and pharmaceutical products for the animal health industry.Reasons why the right person will want this job:

• Step up into a leadership role and manage a small team!
• You are the Validation expert ? You have a seat at the table
• Well-established and growing company ? expanding product offerings
• New Products in both Biologics and Pharmaceutical
• Key player on the team for process development of new products
• Be instrumental in decisions regarding capital improvements
• Team environment
• Advancement potential into a variety of roles
• A consulting group will mentor and onboard you, guaranteeing success
• The company is committed to improvement and has a plan
• Exceptional benefits package ? great vacation plan

JOB SUMMARY:Responsible for supporting the Quality System with oversight of the Pharmaceutical and Biological manufacturing areas from a calibration, validation, and sterility standpoint.The role you will

• Be responsible forall aspects of biological and pharmaceutical manufacturing including:
• sterility assurance-related issues
• calibration
• IQ/OQ/PQ of select manufacturing equipment
• 21 CFR parts 210 and 211 protocols and compliance
• corrective action/preventive actions of sterility failure investigations
• process improvement projects
• compliance programs

• Provide a holistic microbial-contamination control strategy and improvement plan.
• Develop and improve existing controls in the Sterile Fill area.
• Generate periodic quality assessments of critical utilities
• Be responsible for the generation of documentation for biological sterility assurance, validations, and process improvement in pharmaceuticals in the areas of:

IQ/OQ/PQ documents

Calibration

Sterility Failure Investigations

Risk assessments

• Generate SOP's for:
• Temperature Mapping
• Biological Mapping
• Mapping Autoclaves
• Sterility Failures

• Perform and support cleaning validations, writing associated protocols and final reports.
• Assessment of validation requirements for new projects for ANADA submissions.
• Train and Mentor all of staff to help support the daily requirements of calibration and validation of equipment and processes and dedicate themselves to superior quality protocols

Job RequirementsBackground profile:

• BS Degree in Chemistry, Chemical Engineering, Microbiology, Biology, Life Sciences, or Pharmaceutical Process Engineering.
• 5+ years of experience in the pharmaceutical/ biologics manufacturing industry.
• Superior documentation skills in the areas of:

• IQ/OQ/PQ
• 21 CFR [parts 210 & 211
• Sterility assurance
• CAPAs
• SOPs

• Advanced knowledge of:

• ISO-14644
• USP/NSF Guidelines
• cGMP protocols/regulations
• FDA regulations
• Good Engineering Practices & Good Automation Manufacturing Practices
• Root Cause Analysis
• Critical Utilities
• Discrepancy investigations & risk assessment methodologies

• Leadership and team-building abilities (influencing, negotiating, prioritizing, timely decision-making)
• Supervisory experience is a plus
• Have a strong trainer/mentor mentality ? enable those around you to improve their skills
• Demonstrated ability for conceptual and analytical thinking, from a holistic level to a detailed view.
• Excellent verbal and written communication skills.
• Self-Starter - ability to work independently and collaboratively with others
• Advanced ability with Microsoft Office Suite, Internet Software and E-mail.

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