We are seeking a Validation Engineer with the following qualifications: Will design and perform validations for new and upgraded pharmaceutical manufacturing processes, and guide engineering project teams in application of quality and regulatory requirements to projects. Will assist in research, develop and prepare specifications for improvements to existing and/or new products, processes, equipment, and technology. Associate Validation Engineer is accountable for project initiation, planning, overseeing development, testing, implementation, and closeouts from start to finish.
- Prepares, executes, and finalizes protocols (IQ, OQ, PQ, PVP and PVR) for validating current, new and improved manufacturing processes and products under minimal direction.
- Document, coordinate the execution, and summarize qualification activities.
- Maintain existing protocols to be prepare for third parties review upon request.
- Coordinates planning, organizing, integration and completion of engineering project within assigned responsibility.
- Support in design and execute validation plans and programs for new and improved dietary supplement equipment.
- Manage the qualification schedule for the project and ensures deliverables are met and documented per the project plan.
- Occasionally supervise specialized contract personnel and outside vendors in the performance of contract validation services. Represent the company as the point of contact with regulatory agencies, including interface with the FDA inspectors.
- Evaluate existing equipment and processes, investigate and identify new technology developments for ongoing improvements, including automation improvements, machine upgrades, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiency.
- Provides technical input to Manufacturing, Quality and Reliability organizations for failure
- Analysis, root cause and corrective action assessment, and technical training.
Knowledge, Skill and Abilities:
- Direct experience with analyzing and evaluating methods of production to efficiently allocate resources (equipment and labor) including time studies and line balancing.
- Knowledge of U.S. FDA, cGMPs, and QSR.
- Excellent written and verbal communications skills, as well as detail oriented organizational skills.
- Ability to utilize basic computer software such as Microsoft Office, Excel, Power Point, Word, and Outlook.
- Adapt in fast pace work environment and able to deal with multiple critical task/issues.
- 1-3 + years in Quality Engineering, Validation, Industrial Quality Control, and/or Quality Assurance.
- 0 - 3 years of work experience in dietary supplement, medical device, or other regulated industry.
- Bachelor Degree in Engineering or equivalent work experience and education.
- Competitive Wages
- Medical & Dental (company pays 75% of employees HMO plans)
- Discounted Vision
- Life Insurance
- Paid Holidays
- Vacation Days
- Sick Days
This is a non-management position
This is a full time position