Process Validation Engineer

In this role you will manage and execute all process validation activities in accordance and compliance to the GSC Group Quality standards, policies, established quality criteria and technical constraints/specifications.

Main responsibilities: 

• Manages and supervises the Acceptance activities for all Processes during delivery from Industrialization or external suppliers (locally or globally) at the final production site.
• Performs audits at all Machines prior to their release in Production and provides guidance to other sites to support their respective delivery.
• Defines, Manages and Reviews all Process Acceptance protocols.
• Leads the prototype phases of all MPCRs concerning process changes in production.
• Leads the process validations of all Machine upgrades from the Maintenance department.
• Leads the process assemblies needed for mold validations, PCR prototype phase validations, and NP validations.
• Authorizes the release to production of all new procesess.
• Close co-operation on product quality issues with all relative functions and plants.
• Work closely with all the stakeholders including the Project Managers, Engineering, Industrialization and Maintenance department providing guidance and supervision to all validation related activities.
• Lead and/or assist in thorough investigation and root cause analysis of process issues and effective corrective and/or preventative actions to ensure compliance with established Quality objectives and regulations.
• Support all the respective validation documentation according to the ISO 9000 & ISO 17025 approved standards.
• Participate in the weekly tasks’ planning from the overall validation planning update.
• Keep up with technical developments.

Qualifications:

• Technical School or Technical Institute Degree in Engineering will be considered as an asset
• Up to 3 years of working experience in a similar position will be considered as a plus
• Advanced knowledge of English language (both written and verbal)
• MS Excel / MS Power Point knowledge and data processing experience
• Collaboration and communication skills
• Engineering and data analytics mindset
• Time management and ability to work on a few projects simultaneously
• Analytical skills, ability to investigate route cause

BIC World is an Equal Opportunity Employer. We strongly commit to hiring people with different backgrounds and experiences to help us build better products, make better decisions, and better serve our customers. We do not discriminate based upon race, religion, color, national origin, gender, sexual orientation, veteran status, disability status, or similar characteristics. All employment is decided based on qualifications, merit, and business need.

BIC World is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any team member at BIC via email, or directly to a BIC team member in any form without a valid written search agreement in place for that position will be deemed the sole property of BIC, and no fee will be paid in the event the candidate is hired by BIC as a result of the referral or through other means.