Regional Validation Lead

PURPOSE AND SCOPE:

The Regional Validation Lead (NA) will be the hands-on subject matter expert in the field of Validation and Statistical Engineering.

Responsible for developing and leading the regional standardisation of policies, procedures and practices of Validation and Statistical Engineering utilized within the manufacturing network

PRINCIPAL DUTIES AND RESPONSIBILITIES:  


* Identify, define, develop and implement Validation best practices and procedures within the manufacturing network


* Support tech and process transfer projects by establishing efficient PV strategies (VMP), setting up risk-based sampling plans, KPIs and production control measures


* Oversee and guide efforts to manage Process Validation projects in the respective region


* Partner with Site Quality and Regional Manufacturing Quality Leaders to ensure all plant support related to process validation and statistical practices are executed to customer and regulatory requirements


* Consolidate and strengthen PV SME network in the region.

Identify opportunities and leverage on synergies through multi-site collaboration and application of harmonized PV approaches


* Coach and assist PV SMEs, suppliers, production personnel to conduct lean and compliant PV and IPC projects


* Prepare, review, approve and train critical documentation related to process characterization and PV (IQ/OQ/PQ, VMP, Deviation Mgmt.)


* Work in close collaboration with other regional validation leads to drive harmonized process validation processes for new products or manufacturing lines


* Deliver efficient and harmonized Validation and statistical policies and practices across the NA region with full regulatory compliance


* Establish and maintain high level of process validation expertise throughout the validation SME network in the region.


* Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.


* Assists with various projects as assigned by a direct supervisor.


* Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:


* The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


* Bending, Carrying, Kneeling, Lifting, Vision, Hearing and Sitting.


* Travel up to 20% - 30%, may be required

SUPERVISION:


* None

EDUCATION:


* Bachelor’s Degree in Engineering or equivalent required; Advanced Degree preferred

EXPERIENCE AND REQUIRED SKILLS:  


* Minimum of 10 years experience in Quality Assurance, Quality Enginee...