SPECIFIC TASKS/PRIMARY ACTIVITIES

Contribute to the optimal transfer of the production processes requested by the client to the on-site production facilities and their optimization. This is achieved through analysis of the technical specifications transferred by the Technology Transfer team, the possible definition of processes based on the technical specifications, the study of the client's production process, comparison with company processes, gap analysis between the current situation and the desired situation, and the proposal of changes needed for implementation of the new production processes.

Ensure the correct technical and timely assessments needed to prepare Capital Appropriation Requests for financing the assigned projects, respecting the priorities and needs of the requesting Departments.

Ensure the definition of the basic project, the development of design and technical specifications, URS, in line with the needs of the Management and company quality standards.

Support the Purchasing Office in conducting financial negotiations relating to project supplies, adhering to the budget and assigned timelines.

Ensure that activities are managed in line with project technical specifications, quality standards, company procedures and SOPs, and safety regulations.
Contribute to the preparation of appropriate reporting regarding the progress of industrial engineering projects in terms of time, costs, and order status.

This role offers excellent opportunities for professional growth within an established leader in serving science.

REQUIREMENTS:

Bachelor's Degree required, no prior experience required

• Preferred Fields of Study: Chemical/Mechanical Engineering, Biomedical Engineering or related scientific field
• 0–2 years of experience in pharmaceutical manufacturing, engineering, or technical functions within a GMP-regulated environment, preferably sterile.
• Experience in sterile pharmaceutical manufacturing
• Strong knowledge of GMP, validation principles including IQ/OQ/PQ protocols and FDA/EMA regulatory requirements
• Experience with Sterile environmental, equipment design, revamping of existing ones
• Expertise in Microsoft Office suite
• Excellent written and verbal communication skills in English
• Ability to work independently and as part of cross-functional teams
• Strong problem-solving abilities and analytical mindset
• Experience with risk assessment methodologies
• Knowledge of data integrity requirements and 21 CFR Part 11 compliance
• Ability to manage multiple priorities effectively
• Travel between sites may be required
• Flexible schedule may be necessary for time-sensitive validation activities