Equipment Qualification Engineer
Proclinical is currently recruiting for an Equipment Qualification Engineer with a pharmaceutical company located in Elizabeth, NJ.
- Responsibilities include performing equipment, utility and facility qualification activities in addition to support of engineering process improvement projects.
- Support Site Expansion and Renovation activities including Commissioning and Qualification for Facility, Utility and Equipment related systems.
- Write Validation / Qualification protocols and reports that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.
- Analyze data to ascertain if it meets related protocol acceptance criteria; write deviation reports as required upon failures to meet protocol acceptance criteria.
- Compile information from engineering turnover packages and engineering design documentation to support qualification.
- Participate in factory acceptance testing and provide commissioning support.
- Work with Engineering, Operations and R&D to facilitate the launch of new products in an efficient manner. Serve as a technical resource for Engineering and Operations for equipment/process capability and qualification requirements.
- Prepare URS/FRS documents for required equipment for validation related projects.
- Prepare and Execute Engineering Studies to establish equipment operating parameters.
- Support activities to meet the requirements of the approved Site Validation Master Plan and Validation Project Plans.
- Monitor all activities through completion, develop and communicate project timelines and status.
- Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors.
- Other duties as assigned by the Qualification/Engineering management.
Skills and Requirements:
- MUST HAVE equipment qualification and computer system validation experience.
BS in Engineering (or other sciences).
- At minimum, five years of Qualification/Engineering experience in the Pharmaceutical industry specialized in solid oral dose.
- In depth understanding of pharmaceutical equipment function and operation.
- Experience in general quality assurance methods and practices in equipment / process / product validation, quality improvement, quality management systems, corrective and preventive action, root cause analysis.
- Basic understanding of common GMP utilities such as HVAC and compressed air systems.
- Experience with automated control systems such as programmable logic controllers.
- Specialized or Technical Knowledge, Licenses, Certifications required
- cGMP Compliance and FDA PAI and Post Approval Inspection experience is required.
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.