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Lead Process Engineering Specialist
2 months ago
At Virbac, we recognize that animal health is integral to the well-being of our planet.
Joining our team means becoming part of a remarkable professional journey where the commitment of each individual plays a vital role in our collective growth.
We promote internal mobility across various roles and locations, provide personalized development plans, and cultivate a relationship of trust between our managers and employees, all of which serve as motivating factors for our teams.
We also ensure a work environment that encourages exploration of new avenues while maintaining a balance between professional and personal commitments.Moreover, our dedication to animal health involves actively listening to our employees, aiding them in skill acquisition, preparing them for future challenges, and encouraging their contributions towards a more responsible business approach.
Lead Process Engineering Specialist - Technology Transfer
Virbac Animal Health is on the lookout for a Lead Process Engineering Specialist - Technology Transfer to enhance our Manufacturing Science & Technology (MSAT) team.
The Lead Process Engineer will oversee the technology transfer of products from research and development, third-party contract research organizations, and other Virbac facilities, ensuring process efficiency for cGMP planning and execution.
This role will involve collaboration across various departments to effectively address product and process cGMP readiness for manufacturing, planning, and coordination.
The primary focus will be on Oral Solid Dosage (OSD) Forms, including compressed and extruded products, but may also encompass a variety of forms such as liquids, pastes, powders, and suspensions.
Candidates should possess a Bachelor's degree (or equivalent) in a scientific or engineering field and have a minimum of 7 years of experience in product or process development, with at least 5 years in a Pharmaceutical/FDA regulated environment. This position may require occasional travel.This exciting opportunity is based in a dynamic environment and includes a comprehensive benefits package, such as generous time off, 401k with matching, life insurance, medical, dental, and vision coverage, among others.
Lead Process Engineering Specialist - Technology Transfer
Key Responsibilities
1. Oversee scale-up and technology transfer of new products:
- Ensure the development of robust and efficient manufacturing processes.
- Independently design experiments and conduct scientific investigations.
- Lead risk assessments with key cross-functional stakeholders and establish control strategies.
- Develop control strategies for new products to enhance efficiency, robustness, and compliance.
- Participate in core team meetings to ensure collaboration with cross-functional stakeholders.
- Execute engineering studies to qualify products, processes, and equipment.
- Manage multiple projects, prioritizing effectively to focus on critical initiatives.
Expected Outcomes: Ensure robust, efficient, and compliant manufacturing processes.
2. Conduct process engineering studies to introduce new and improved processing techniques and technologies:
- Create scale-up models by developing a comprehensive understanding of processing equipment at various scales.
- Design and execute studies to evaluate process parameters, troubleshoot issues, and optimize performance.
- Lead and/or support the compilation of process data.
Develop a deep understanding of how critical product quality attributes can be influenced by processing and controlled accordingly.
Expected Outcomes: Enhanced process and equipment understanding, control, and capability.
3. Develop process engineering documentation and support GMP manufacturing:
- Author, review, and approve GMP-critical documentation, including experimental reports, batch records, and process work instructions.
- Support GMP product and process investigations, including deviations, change controls, and CAPAs.
- Create investigation and research plans aligned with overall project objectives.
- Conduct manufacturing process reviews for technology transfer, highlighting critical process parameters and material attributes.
- Write and/or review CMC regulatory documents.
Expected Outcomes: Ensure proper documentation for training and compliance requirements.
Candidate Profile
Qualifications:
- Bachelor's degree (or equivalent) in a scientific or engineering discipline.
- Minimum of 7 years of experience in product or process development, with at least 5 years in a Pharmaceutical/FDA regulated environment.
- Familiarity with cGMP standards and experience in a regulated setting.
Skills:
- Strong analytical thinking and problem-solving abilities.
- Proven success in cross-functional team environments.
- Self-motivated team player capable of prioritizing and delivering results with minimal supervision.
- Excellent verbal, written, and interpersonal communication skills.
- Strong organizational and computer skills.
- Experience in capital project design, development, and execution.
- Prior experience with OSDs, including granulation, tablet compression, and/or extrusion.
- Familiarity with lean and six sigma principles and tools.
- Willingness to travel up to 10% of the time.
At Virbac, we offer a wealth of career opportunities, driven by the diversity of our roles and their international scope.
Joining Virbac means becoming part of dynamic teams that are ambitious for success.
Add Your Expertise to Our Vision.
