Director Technical Center
Director Technical Center
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Director Technical Center is responsible for new product process and technology development validation and transfer into Manufacturing and for sustaining engineering and revalidation posttransfer. Responsible for the creation of process and technology improvement strategies and business cases.
The team will implement manufacturing and production processes and process improvement from validation to production scaleup to meet product and process design specifications and throughput requirements. Responsible for resolution of all processrelated production issues including proactive monitoring of the process to ensure process stability and consistency.
In addition the team is responsible for line extensions and packaging changes throughout the lifecycle of the product portfolio.
Responsibilities:
- Manages experienced technical people managers to lead and provide Operations technical support for new product equipment process and technology development transfer and launch. Includes the sustained manufacturing and validated state of all products processes equipment and technologies posttransfer. Scope includes technical activities such as: operations requirements and specifications design for manufacturing writing specifications and SOPs validation strategy and planning qualifications and validations revalidations process monitoring and the coordination of new launch builds.
- Serves as Operations subject matter expert on product design features and requirements and process requirements and limitations. Ensures the identification of continuous improvement opportunities and the development of business cases strategies plans timelines and budgets for execution.
- Active partner with Operations Quality PDS&T R&D and Regulatory Affairs to ensure customer satisfaction of both product quality and availability and compliance with the manufacturing processes provides support for regulatory filings and ensure the scientific robustness of the process and raw materials.
- Serves on Site Leadership Team to help set strategy for the manufacturing site with a focus on Manufacturing Equipment and Process Engineering requirements and compatibility of the processes and designs with the manufacturing environment.
- Ensures timely leadership and/or support of technical CAPA including thorough investigations root cause analysis and identification and corrective and preventive actions to address root cause.
- Establishes departmental operating policies and procedures. Creates and manages budgets for the Process Engineering and Validation Engineering teams. Sets departmental goals. Coaches and develops team performance as well as individuals performance.
Qualifications :
- Bachelors degree in Science Engineering or related discipline with 15 years experience.
- Minimum 12 years product and/or process development or related experience with medical devices or pharmaceuticals.
- Masters Degree in Engineering or Material Science (10 years experience) is preferred.
- 10 years experience in a Medical Device environment.
- Experience with Quality System Regulations (QSR) and Design Control AATB ISO and/or FDA guidelines as related to Human Tissue Processing and Medical Device Manufacture.
- Demonstrated experience with new product development and/or technology transfer in the medical device industry.
- Experience using principles of design for manufacturability lean and Six Sigma in the medical device or pharmaceutical field.
- Experience with Sterilization Validation Standards preferred.
- Six Sigma Certification Value Stream Mapping Lean Manufacturing and experience with biologicbased products preferred.
- Experience with leading people managers through talent development project planning and goal attainment with a demonstrated ability to analyze issues and develop and deploy solutions within a dynamic environment.
- Experience with root cause analysis methods.
- Excellent understanding of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
