Commissioning & Qualification Specialist
Flexible & Integrated Technical Services View all jobs
- Juncos, PR
- Permanent
- Full-time
- Bachelor’s Degree in Life Science or Engineering and a minimum of five (5) years of experience in the regulated industry.
- Excellent written and verbal skills in both English and Spanish.
- Technical writing skills and problem-solving skills.
- Experience in:
- Facilities, utilities, drug substance, filling, inspection, and packaging areas
- Equipment qualification
- Validation concepts and life cycle process.
- Conceptual, detailed design, project planning, execution, and qualification
- Validation Commissioning Qualification Technical Writing Protocol Drafting, Review, Execution Deviation Process Documentation
- Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
- Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.
- Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.
- 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!