Assoc. Director Maintenance

Job Description

Lead a high-performing team to maximize equipment reliability drive strategic maintenance and reliability projects.

The Mechanical Services Engineer Associate Director (AD) position will ensure reliable performance of equipment by providing support for complex troubleshooting and repairs of equipment as well as supporting Technology and Quality during equipment investigations and modifications. The successful candidate will be responsible for aligning maintenance projects with the business objectives around Safety Compliance and Cost. The Mechanical Services Engineer AD must be able to self-identify opportunities for improvement and lead a team of talented mechanical service engineers.

Position Description:

Primary responsibilities for this position include providing tactical and strategic direction to the BCG maintenance engineering team in support of BCG operations. This includes ensuring that business objectives are met at a high standard for Quality EHS compliance is maintained and the team operates efficiently and within budget. The position will also be expected to promote continuous improvement and maintain an inclusive and positive culture within the team.

Responsibilities:

• Analyzes calibration maintenance and equipment performance and work orders to identify trends with an emphasis on reducing reactive work and increasing reliability

• Identifies revisions deletions or additions to the calibration and maintenance programs and Standard Operating Procedures (SOPs) to ensure that calibration and maintenance activities are completed in accordance with established safety Good Manufacturing Practice (GMP) and calibration/maintenance procedures

• Ensure required Safety guidelines are followed and participates in divisional Safety Audit activities

• Leads deviation investigations for instruments equipment and system failures ensuring events are well-investigated and well-documented while meeting timing commitments

• Lead in the identification and implementation of process improvement projects productivity initiatives and corrective actions while focusing on equipment up-time minimizing cost and maintaining process consistency

• Support safety programs such as Lock Out/Tag Out (LOTO) Hazardous Energy Control Procedures (HECP)

• Collaborates with the Technical Center of Excellence (CoE) Reliability Engineers to conduct periodic Risk Based Asset Management (RBAM) assessments and own area specific reliability actions

• Ensure accurate Bill of Materials (BOMs) and Equipment information in Computerized Maintenance Management System (CMMS)

• Perform root cause analysis and implement corrective actions and preventive actions (CAPA)

• Ensure accurate MTTR and MTBF data collection

• Establish and lead the condition monitoring strategy of the equipment (use of PI vibration ultrasound infrared motor testing balancing non-destructive testing and machinery lubrication)

• Establish metrics Key Performance Indicator (KPIs) to improve equipment performance

• Develop lead and implement reliability improvement and/or capital projects with cross functional teams

• Lead and conduct Failure Mode and Effect Analysis (FMEA) activities

• Proficient in Reliability Engineer for Maintenance elements (RCM FMEA RCA)

• Coach and mentor Associate Specialist Specialist and Senior Specialist Engineers

Position Qualifications:

Education Minimum Requirement:

• Bachelors Degree or higher in Engineering Science or related field

Required Experience and Skills:

• Minimum of eight (8) years in a production and/or calibration and/or maintenance background

• Strong planning scheduling and time management skills

• Working knowledge of regulatory requirements in accordance with current Good Manufacturing Practice (cGMP) manufacturing operations

• Good oral and written communication skills

• Experience with Good Manufacturing Practice compliant calibration and maintenance databases

Preferred Experience and Skills:

• Experience with vial filling lyophilization sterile supply and contained restricted access barrier (cRAB) equipment.

• Experience with formal problem-solving techniques such as root cause analysis (RCA) failure mode effects analysis (FMEA) and/or company Production System (MPS) tools

• Experience in deviation management and demonstrate complex problem-solving capabilities

Additional activities responsibilities and competencies include but are not limited to the following:

• Accountable for ensuring all processes performed and managed by maintenance and engineering team are following cGMP and EHS regulations.

• Investigate and resolve compliance gaps identified through the audit program or deviation investigations.

• Manages capital projects ensuring that project estimates are accurate projects are executed against spending budget delivered on time and closed in a timely manner.

• Responsible for equipment reliability and uptime for the production support drug substance and drug product areas. Actively monitors equipment performance and downtime and works to improve equipment reliability drive continuous improvement and efficiency.

• Develops and executes site energy conservation programs focused on sustainability.

• Provide leadership to the team engineering team including coaching development and performance management.

• Ensure culture of inclusion and consistency is maintain that supports a positive work environment within the engineering and maintenance team.

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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 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.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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