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Company Contact Info
- Paramus, NJ 07652
- Avi Persaud
- Phone: 2126726961
- Phone:: 1 203-905-5298
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Director of Engineering
Michael Page • Paramus, NJ
Posted 2 months ago
This position will work in close cooperation with Manufacturing, Engineering and other functional areas in managing validation activities under the QE scope of work. Responsible for presenting validation practices during the regulatory agencies and customers audits.
Our client is a Fortune 500 industrial manufacturing organization located in the Northern New Jersey area.
- Hire, manage, and develop teams to support validation activities at both locations
- Manage continued growth, development, and retention of the team
- Set strategic direction for the QE organization
- Responsible for making key decisions and formulating policies that are aligned with strategic objectives of the QE function
- Collaborate with Manufacturing, Engineering, QA and other functional areas in managing validation activities under the QE scope of work
- Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases
- Develops key performance metrics that measure the effectiveness of the QE organization
- Develop validation master plan (VMP) to assure compliance with regulatory requirements
- Oversee or independently develop a cleaning validation strategy for equipment and parts. Develop and execute or approve cleaning validation protocols and generate validation reports
- Oversee or independently plan and execute validation studies for equipment, facilities/ utilities and cleaning
- Write validation protocols, validation final reports and Standard Operating Procedures (SOPs), and technical reports
- Draft or review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures
- Conduct and document investigations related to validation activities
- Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
- Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per FDA, and other regulatory agencies requirements. Contribute to GMP systems improvements
- Bachelor's Degree in science related field (engineering, chemistry, or equivalent)
- Minimum of 10 years pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) including experience in writing and execution of protocols, reports and operating procedures
- At least 5 years of experience in people management and leadership
- Experience in drug GMP manufacturing
- Strong knowledge of GMPs, FDA & EU guidelines/requirements related to validation
- Experience with root cause analysis, failure mode analysis and analyzing complex technical problems. Possess sound technical judgement
- Experience in writing standard operating procedures and technical reports
- Excellent written and oral communication skills
- Proficient computer knowledge, including Microsoft Word, Excel and PowerPoint
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Ability to work independently and manage one's time
- Communicate effectively and ability to function well in a team environment
- Fortune 500 Company
- Competitive base salary
- Opportunity for growth
- Great work life balance