Reliability Engineer

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing and packaging of complex oral solid dose, liquid, and semi-solid pharmaceutical Rx and OTC products for clinical and commercial uses. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

JOB SUMMARY

The Reliability Engineer is responsible for the development, implementation, and sustainability of the equipment reliability program at Bora Pharmaceuticals Camden site in Baltimore. This position will align the continual improvement program and guidelines for maintenance and calibration activities with global Engineering, Facilities, and Validation initiatives.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Analyze repetitive failures of equipment.
• Implement and sustain predictive maintenance program using data such as vibration and infrared analysis, chemical analysis of lubricants, etc.
• Design maintenance and calibration strategies, procedures, and methods to achieve asset reliability. This includes balancing predictive maintenance methodologies with traditional preventive maintenance schedules.
• Investigate thorough root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future internal and external audit observations with the same or similar root cause.
• Conduct risk-based analysis to determine maintenance and calibration intervals.
• Lead and participate in cross-functional teams for Root Cause Failure Analysis, Failure Mode Effects Analysis (FMEA), and maintenance improvement strategies to prevent premature failure of critical equipment.
• Support key performance metrics. Prepare periodic statistical updates and reports to maintenance and calibration program stakeholders.
• Obtain equipment spare part information for creation of material masters and Bill of Materials.
• Assess need for equipment replacement and establishing replacement programs when due.
• Support improvements to the maintenance and calibration CMMS.
• Implement maintenance and calibration program improvements both independently and through collaboration with on-site stakeholders.
• Maintain a current and detailed knowledge of cGMP.
• Perform work functions in alignment with quality systems such as change controls, deviations, and corrective and preventive actions (CAPAs).

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:

• Bachelor’s degree in Engineering or related area of study, or suitable combination of skills and experience within the life sciences industry.

Experience:

• 5 years of maintenance experience in a GMP manufacturing environment.
• Prior development of preventive and predictive maintenance plans.
• Quality system functions including change controls, deviations, corrective and preventive actions (CAPAs), and audit responses.

Skills:

• Familiar with computerized maintenance management systems (CMMS), preferably the SAP Plant Maintenance module.
• Solid understanding of proactive maintenance systems as well as continual improvement strategies included in lean manufacturing.
• Able to interpret industrial drawings and technical specifications for projects.
• Able to collect, record, analyze and interpret data.
• Excellent oral/written communication and computer skills with the ability to create reports develop tables and work with formulas.
• Proficient with the use and application of Microsoft Office suite of programs.
• Working knowledge of laboratory practices and manufacturing experience would be an asset.

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.