Blue Mountain RAM Admin/ Reliability Engineer at USDM Life Sciences

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM Life Sciences is seeking an innovative, highly motivated, versatile candidate to join us as a contract BMRAM Administrator / Reliability Engineer. The successful candidate will be responsible for the oversight of the Computerized Maintenance Management System (CMMS) and Planning/Scheduling of General Work, Preventative Maintenance, & Calibrations.

Primary Responsibilities

• Establish facilities contracts to support facilities, calibration, HEPA Certification, HVAC Balancing, roof repair, welding, machine shop, electrical, office moves, pest control, safety, security/ access control, and janitorial.
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• Ensure utilities, Standby generators, NIST Instruments, electrical/ UPS systems, HVAC Systems, HEPA Filters, and process equipment are maintained per preventative maintenance/ HEPA Certifications/ Calibration Programs.
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• Manage the administration and execution of the GMP MFG Facility Site CMMS (Blue Mountain) and  Site BMS and EMS (GMP and nonGMP).
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• Establish MFG Facility Site equipment/ system spare parts inventory and integrate into the CMMS.
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• Create an inventory list, assign part numbers, create barcodes, and upload inventory into CMMS module.
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• Support asset classification and perform criticality assessments, rating equipment criticality and assigning appropriate maintenance plans based on criticality rating.
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• Integrate Preventative Maintenance Work Plans associated with each piece of equipment/ system to ensure plans will be consistently executed and documented by contractors/ technicians.
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• Manage the MFG Facilities process equipment, facilities, utilities, and HVAC equipment spare parts requirements to ensure required like-for-like spare parts are on hand to support facility uptime.
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• Comply with manufacturing site change control documentation and support change efforts with technical team.
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• Prepare for inspections by reviewing all maintenance SOPs, practices, and training documentation for completion and accuracy.
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• Manage the central electronic repository for engineering drawings.

Additional Responsibilities

• Assist in project management by reviewing and redlining P&IDs and meeting with contractors to ensure timeline and quality adherence.
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• Support the Capital Project Strategy, Design, Specification, RFP Procurement, and Project Management.

Qualifications

• Possess pharmaceutical engineering operational knowledge (e.g., process equipment, utilities, facilities, PM, Calibration, validation, scheduling).
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• 5+ years of process equipment, utility, PM, calibration, cGMP/ GLP environments, and regulations experience required.
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• Must possess a strong ability to negotiate and influence others internally and externally.
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• Ability to work flexible work schedules.
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• Excellent computer, verbal, and written communication skills.
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• Innovative approach to problem-solving, an integrated view of business/ scientific issues, and a strong work ethic.
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• Possess and demonstrate exceptional problem-solving skills.
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• Proven ability to work in a lean organization and creatively tackle problems.
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• Work independently in a matrix environment and manage multiple tasks simultaneously.

Education & Certifications

• 5+ years of biopharmaceutical GMP Facilities/ RCM, engineering, or manufacturing experience required.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

  Unless reasonable accommodations can be made, while performing this job the staff member shall:

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• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
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• Operate other office productivity machinery, such as a calculator, scanner, or printer.
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• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 45.00- 55.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers