Reliability Engineer – Equipment focus - OQSIE

Integrate best-demonstrated practice and industry standards into reliability and maintenance programs

· Create detailed reliability standard operating procedures that encompass preventative and predictive methodologies and best practices

· Create comprehensive maintenance management procedures which include elements such as:

o Clear definition of the management process and maintenance strategies

o CMMS management equipment classification and risk-based analysis

o Health and safety policies

o Maintenance and repair operations (MRO) management

o Project management of equipment modifications and improvements

o GMP considerations

o Maintenance assessments

o Equipment documentation and change control

o Equipment importance level, based on the corresponding failure-based risk assessments.

o Supplier information alignment

· Develop equipment specific preventative maintenance procedures based on risk-based analysis and vendor recommendations

· Develop new and/or update equipment operating procedures to cover maintenance frequency of new and existing assets.

· Participate in FAT and commissioning of new or modified equipment.

Qualifications

· BS in Engineering, Science, or equivalent technical degree.

· 2-10 years' experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.

· Experience in:

o Maintenance Strategies and Management

o Computerized Maintenance Management Systems

o Maintenance and Repair Operations and Management

o Equipment design documentation (URS, FS, DS and other engineering specifications)

o General knowledge of Medical Device Quality Management Systems (Change Control, Non-Conformances, Requalification, etc)

o Process Excellence Methodologies (Six-Sigma, Lean, etc.).

· Excellent written and verbal communication skills; excellent technical writing skills.

· Strong interpersonal skills and the ability to work in a team environment.

· Ability to work effectively in a fast-paced multitasking environment.

· Strong working knowledge of FDA and cGMP regulations and documentation practices.

· Proficient in Microsoft Word, Excel, PowerPoint.