Specialist, Engineering, Maintenance & Utilities

Job Description

ACCOUNTABILITY

Under the supervision of a Senior Specialist or Associate Director, this individual is responsible to provide day-to-day equipment and facility engineering support for their assigned area. Actively ensures compliance to current Good Manufacturing Practices, Safety, and Environmental regulations while achieving operating cost goals. Assigned area(s) may include: vaccine bulk manufacturing, formulation/filling, lyophilization, packaging, and/or support utilities including power, HVAC, steam, WFI, and controlled temperature units.

Assigned tasks may include:

• Support and monitoring of equipment performance

• Equipment maintenance

• Developing equipment and facility improvement plans

• Troubleshooting process equipment to ensure reliable, compliant and efficient operations.

• Execution of equipment lock-out tag-out (LOTO)

DUTIES

• Provides day-to-day shop floor equipment, instrumentation, robotic & utilities engineering support to manufacturing operations.

• Assists/leads operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction.

• Ensures adequate spare parts inventory.

• Assists in the facilitation of maintenance work, including leading JSA/LOTO execution, directing mechanic labor, and identifying spare parts.

• Responsible for ensuring CMMS/EAM data is up to date and accurate for their assigned equipment.

• Provides technical assistance in the maintenance planning process.

• Optimizes and coordinates scheduling of preventative, predictive & corrective maintenance to improve equipment reliability.

• Develops and maintains metrics used to run the business. Communicates and presents metrics/reports regularly.

• Champions the preventive and predictive maintenance program within your area of responsibility, reviews equipment history for reliability concerns, performs root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs. Develops maintenance and repair strategy for bi-annual shutdowns.

• Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations. Collaborate with operations for day to day priorities, maintenance scheduling, deviation management, etc. Effectively influences and collaborates with stakeholders and partners outside of their immediate organization.

• Provides supervisory coverage when required.

• Promotes open communications and team work.

• Maintains a high level of technical knowledge and may coordinate safety, current Good Manufacturing Practices, and environmental compliance programs.

• Actively supports productivity improvement program and resolution of deviation events. Participates in root cause investigations.

• Evaluates, develops and improves business processes and develops technical rationale for system improvements.

• Develops Qualification, SOP and Preventative Maintenance documentation and provides reports, data and

• information to support on-going operations.

• Serves as the project engineer and manager for projects including scope development, design support, field execution and commissioning/qualification testing.

• Develops strong relationships with site operations to ensure consensus on operational and regulatory compliance issues.

• Explains and enforces all GMPs, safety, and environmental regulations.

• Assist in audits, regulatory inspections and training in the area of responsibility.

• Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors.

• Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan.

QUALIFICATIONS:

Essential:

• B.S. Engineering, Science, or 4 Year Engineering Technology Degree.

• Minimum of two (2) years of relevant work experience, including:

• Equipment troubleshooting

• Facilitating work execution

• Identifying and executing continuous improvement projects

• Maintenance data management/improvement

• LOTO

• Demonstrated ability to work independently and as part of a team.

• Proficient in the following competencies: empowering leadership, flexibility, motivation, teamwork/collaboration, problem-solving, communication, and computer skills.

• Knowledge in the application of engineering standards (i.e. ASME, IEEE, NFPA, CFR 1910, NIST, and/or ANSI).

Preferred:

• Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing

• Lean Six Sigma Methodology

• Root Cause Analysis

• Failure Mode Effects Analysis

• Knowledge in reliability engineering (including asset life cycle management)

• Computerized Management Maintenance Systems: SAP/EAM/Maximo/etc.

• CMRP certification

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

VETJOBS

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation: