JOIN OUR TEAM!
PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
Location - Ponce, PR
JOB DESCRIPTION
Responsibilities may include the following and other duties may be assigned: Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing or new products; Integrates equipment and material capabilities to meet process module target specifications and technology target specifications; Reviews product development requirements for compatibility with processing methods to determine costs and schedules; Interacts with product design and development personnel to ensure that processes and designs are compatible; May develop and conduct statistical analysis or recommend additions to document work; Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations; Develop, execute, and close protocols required as part of the validation lifecycle; Supports equipment installation and assessment of inputs, outputs and alignment to requirements; Ensures processes and procedures are in compliance with regulations; Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
Resources are needed to work in new products and capacity increase projects. Main tasks will be to work with all documents of the validation lifecycle including development, execution and closure of documents/reports. Person needs to be able to work with root cause analysis and troubleshoot process, product and equipment as needed.
What are the top 3 things you are looking for in a candidates experience:
- Troubleshooting skills
- Validation lifecycle
- Root cause analysis
- Must be fully bilingual
Education Required: Engineering degree
Years’ Experience Required: 2 years
PharmaLex is an Equal Opportunity Employer.
Top Skills
What We Do
PharmaLex is a leading provider of specialized services for the pharma, biotech and medtech industries.
We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.
The PharmaLex Group now has over 3000 employees, with 68 offices in 32 countries and more than 1000 satisfied clients worldwide.
