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Senior Process Engineer
hace 1 mes
The Senior Process Engineer will lead and execute local and regional projects for development of manufacturing processes, reformulations, and continuous process improvement for solid, liquid, and semi-solid pharmaceutical presentations.
This position requires a strong understanding of technical principles and practices to influence business decisions based on sound scientific rationale.
The ideal candidate will have experience with pharmaceutical or related industry processes and systems, including product development, validation, technology transfer, and life-cycle management of products.
Responsibilities include:
- Leading life cycle management projects for technology transfers, cost reduction, BCP development, manufacturing processes optimization or new technology implementation.
- Applying intensive and diversified knowledge of technical principles and practices to influence business decisions.
- Executing technical activities related to life cycle management projects, including historical data review, product and manufacturing process assessment, development plan and other technical documents elaboration, pilot and/or trial execution, specifications and standard procedures review, etc.
- Providing technical support to manufacturing processes validations, cleaning & sanitization validations, and production campaigns development.
- Supporting investigations, CAPA, and troubleshooting events related to raw material, product composition, manufacturing process design, or consumer complaint.
- Collaborating with local, regional and global teams to guarantee compliance, processes harmonization, and leverage best practices across manufacturing sites.
- Coaching and promoting the development of less experienced teammates.
- Managing expenses related to execution of life cycle management projects and reporting progress to Technical Operations regional leader.
Requirements
Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering or correlated areas is required.
At least 5 years' experience within the pharmaceutical or related industry is required.
Advanced English is required.
Experience with pharmaceutical or related industry processes and systems, including product development, validation, technology transfer, and life-cycle management of products is required.
Experience in technical writing, cGMP's, ANVISA/COFEPRIS/FDA/ICH regulations is required.
Knowledge of regulatory requirements in Mexico is a plus.
Knowledge in statistics (DOE, process capability, control charts, etc) is a plus.
Demonstrated leadership skills to align multi-functional team members on delivering project deliverables is required.
Ability to manage complexity and to work collaboratively with critical stakeholders at local, regional, and global levels is required.
What's in it for you
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
Learning & Development Opportunities
Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
