Validation Manager - Charlotte, North Carolina United States-
Degree Required:University - Bachelor's Degree/3-4 Year Degree - B.S in Chemical, Biochemical or Mechanical Engineering or related discipline is required for this position.
Why is This a Great Opportunity?
We are looking for a Validation Manager who is an experienced people manager, with technical knowledge of pharmaceutical aseptic filling operations and equipment and solid dosage operations and equipment. In addition, the candidate will be responsible for leadership of highly complex compliance projects and initiatives such as New Product Introduction and Cleaning Validation Program. These projects require close collaboration Quality as well as other departments. This individual will also contribute to department efficiency initiatives. This candidate will sit on the technology validation cross functional teams. The candidate must provide mentorship and direction to staff on execution of the Qualification/Validation Lifecycle.
The candidate must have demonstrated capability to effectively manage complex projects in a GMP environment, innovate and deliver business systems. The candidate must have knowledge of pharmaceutical quality systems and Qualification practices. A good understanding of aseptic filling unit operations and controls and drug product process validation is highly desired. A good understanding of resource forecasting is also highly desired. The candidate must be highly self-motivated, have excellent organization and communication skills, be willing and able to work independently and as part of a multi-disciplinary team. The candidate must be comfortable with change and be willing to establish and work towards the future vision for the organization.
- Developing a strong documentation package, involving form conceptual study to various phases of project like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
- Responsible for timely completion of projects to meet the company objectives.
- Responsible for qualification and documentation related to engineering department.
- Responsible for workload forecasting and ensuring effective work processes& procedures are in place and are being followed / used by all the team members
- Accurate estimation of budget for CAPEX and managing the same within the approved budget.
- Conduct regular project review meetings within the team, with cross functional teams and with the vendors to control the project time to time.
- Experience in developing Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, safety analysis etc of biopharmaceutical processes
- Should have hands on experience in conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.
- Should have hands on experience with process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, CIP/SIP sequences
- Working experience in reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation.
- Ability to work in a team structure; plan, organize and prioritize work
- Ability to analyze quantitative data, create and/or edit written reports and be able to process information.
- A minimum of a B.S in Chemical, Biochemical or Mechanical Engineering or related discipline is required for this position.
- An M.S., M.B.A. or other advanced technical or business degree is desirable.?
- Minimum of six (6) years of relevant experience; for example pharmaceuticals, medical devices, chemical, biochemical, or mechanical engineering.
- Must be proficient in AutoCad, MS Office; knowledge of MS word, Excel, database management and statistical analysis
- Must have strong verbal, written and interpersonal communication skills, especially needed to work in a cross-functional team setting
- Effectively organize and manage work responsibilities independently.
- Time and project management skills with the ability to multi-task are essential.
We are a Large International Staffing, Recruitment and Executive Search Firm based in Toronto , Ontario but recruit throughout North America, Asia and Europe in all areas of I.T. , Sales and Marketing , Accounting & Finance , Human Resources, Engineering, Manufacturing , Operations and Health Care
Role: Validation Manager
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