Sr Engineer
Quality Consulting Group
- Juncos, PR
- Permanent
- Full-time
- Develop engineering policies and procedures that affect multiple organizational units.
- Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
- Ability to interpret and apply GLPs and GMPs.
- Comprehensive understanding of validation protocol execution requirements.
- In-depth knowledge of validation processes and requirements as applied to new equipment installations.
- Bachelor’s degree in Engineering
- Five (5) years of Engineering experience
- • Knowledge and experience working with Change Controls on trackwise. (Prefer experience that we are looking)
- Knowledge in Packaging equipment.
- Knowledge in Design of new equipment process.
- Knowledge in Engineering Project
- Knowledge in Validations and Commissioning
- Experience in Medical Device or Pharma
- Knowledge in CAPA and Compliance
- Availability for 1rst and 2nd shift