Bachelor's Degree in Life Science or Engineering with experience in Validation Life Cycle in the Pharmaceutical Industry.
Bilingual in Spanish and English.
Administrative shift availability based on business needs.
Proficient in writing documentation in English and using MS Office applications.
Proven experience with biopharmaceutical manufacturing equipment in the pharmaceutical or biotechnology industry.
Strong understanding of pharmaceutical manufacturing processes, equipment requirements, and cGMP regulations.
Expertise in equipment qualification, commissioning, and validation activities.
Responsibilities
Serve as a technical Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment.
Provide technical guidance on equipment selection, specifications, functionality, and performance.
Support equipment evaluations, troubleshooting, and technical problem-solving.
Collaborate with Engineering, Project Management, Manufacturing, and cross-functional teams on equipment-related activities.
Ensure compliance of equipment-related activities with cGMP requirements and quality standards.
Provide technical input for equipment documentation and project deliverables.
Support equipment commissioning, qualification, and validation activities as needed.
Identify equipment-related risks and develop technical solutions.
Benefits
Exceptional customer service experience within the team.
Opportunities for professional growth and development.
Engagement in a diverse work culture.
Commitment to environmental sustainability.
Full Job Description
For Biopharma Equipment SME services.
WHAT MAKES YOU A FIT: The Technical Part:
Bachelor's Degree in Life Science or Engineering, and previous years of exposure in Validation Life Cycle within the Pharmaceutical Industry.
Bilingual (Spanish & English)
Shift: Administrative, and according to business needs.
Good skills in writing general documentation in English and using MS Office applications.
Experience in:
Proven experience with biopharmaceutical manufacturing equipment within the pharmaceutical or biotechnology industry.
Strong understanding of pharmaceutical manufacturing processes, equipment requirements, and applicable cGMP regulations.
Strong expertise with equipment qualification, commissioning, and validation activities.
The Personality Part:
Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you're creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we're looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job):
Serve as a technical Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment.
Provide technical guidance on equipment selection, specifications, functionality, and performance.
Support equipment evaluations, troubleshooting, and technical problem-solving.
Collaborate with Engineering, Project Management, Manufacturing, and other cross-functional teams to support equipment-related activities.
Ensure equipment-related activities align with applicable cGMP requirements, quality standards, and site procedures.
Provide technical input and support for equipment documentation and project deliverables.
Support equipment commissioning, qualification, and validation activities as needed.
Assist with identifying equipment-related risks and developing appropriate technical solutions.
BEING A FITS PIECE COMES WITH PERKS:
One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you'll be amazed). However, that's not all we have to offer. Talk with us to find out!
