3737 Facilities Leader

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

We don’t follow footsteps. We create the path.

Primary Duties

The Engineering Operations Lead for 3737MS is the technical leader responsible for managing and providing oversight to the team accountable for day-to-day engineering operations and overall maintenance/reliability lifecycle of the Spark Manufacturing Facility, Quality Control & Analytical Sciences; Manufacturing Sciences & Technology equipment & facilities.

• Functional areas of responsibilities under this remit include Engineering (Automation, Process, Analytical Equipment / Systems, Facilities Equipment / Systems & Infrastructure, Reliability); Maintenance; Metrology; Managed services.
• This position will serve as the Lead-End User (LEU) for Engineering Operations at the site being responsible for the Technical Operation, Engineering Design / Functionality, Maintenance and Reliability of all operations and processes onsite.
• This position will support and act as the primary liaison to Spark Capital Feasibility / Execution teams and Global Engineering teams for strategic initiatives and large CAPEX projects to help ensure successful implementation and continuously improve engineering systems / methods / standards as they are applicable. The Site Engineering operations team will own all engineering operations and site facility/engineering change management.

Responsibilities

Develop, Support and Execute Spark’s Site Engineering operational infrastructure and competencies for the short, medium, and long- term needs of the organization and align with Spark’s strategic business priorities. Ensure all functional areas are compliant with all relevant regulations and GMP requirements as they relate to site operations.

• Develop and execute a strategic site engineering operations plan that supports both Spark’s corporate vision and the needs of the growing Technology Development & Operations Organization. Demonstrate strong leadership by aligning Engineering competencies and disciplines with site operations, business objectives and ensuring clear support models are in place to efficiently meet end users’ needs. Establish relationships with all levels of leadership in the organization including senior management, functional stakeholders, and 3rd party vendors to ensure the site portfolio remains operational and efficient.
• Provide leadership and guidance to Engineering Operations Team(s) to ensure effective management of the engineering, metrology, maintenance, project management programs for Spark’s site operations and processes and ensure continuous improvement for cGMP and Scientific processes and support all equipment/systems/Infrastructure (Process, Analytical, Automated, Facilities Utilities & Infrastructure).
• Accountable for project management work to include contributing to annual budgets (CAPEX and OPEX) for sustaining elements Engineering, Maintenance and Metrology, including operational costs, small CapEx improvements / modifications, Overall Capex Lifecycle Maintenance, providing oversight and support to project execution on all capital projects as a key end user / stakeholder representative, and resolution of all engineering and maintenance work problems as they relate to the site.
• Manage and optimize an effective site engineering and Maintenance team to support routine day to day operations, performance analysis, troubleshooting and continuous improvement of processes / equipment / systems for the existing Adherent Process and new Suspension Process. Ensuring that all personnel are fully aligned to their customer needs and requirements, providing an excellent level of service, utilization of the CMMS system for Work Order Management, Periodic Preventative Maintenance & Calibration scheduling, Bad Actor management and other key CMMS and Calibration functions. Maintain and execute cGMP/cGLP/cGCP PM’s, calibrations, repairs with trained Maintenance / Metrology personnel and contract support as required.
• Establish, maintain, and distribute Key Metrics for each group in the Site Engineering Operations Team. Ensure transparency and collaborate with other Site Engineering Operations teams.
• Build out a Site Reliability Program developing appropriate metrics and including key functionality in the areas of Work Order Management, Bad Actor Management and Predictive Maintenance (Vibration, Thermography, Ultrasonic, Oil Analysis etc…).
• Collaborate w/Spark EHS to build out a site Sustainability Program for Energy Monitoring and savings. Collaborate with Global Engineering, Spark EH&S and other Site Engineering operations teams to ensure alignment and appropriate reporting.
• Develop and maintain a comprehensive MRO Spare Parts program for the site ensuring proper forecasting, site capacity and controls, max / min re-order points, with proper future expansion and flexibility as applicable.
• Ensure site projects are executed safely, efficiently, and in accordance with all applicable codes and works closely with EHS on all Operational Environmental, Health and Safety Elements within GTIC.
• Manage / Own all Site Engineering Automation Operations. Automation team will support day to day operation and immediate troubleshooting. Automation team will serve as liaison with Global Automation Engineering Team and support all site automation engineering strategy development and execution. Support all Global Engineering Initiatives and continuous improvement. Escalate advanced issues to Global Automation team as necessary.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance.
• Manage / Own the Site CMMS (Computerized Maintenance Management System) and Calibration system.
• Ensures projects and routine work are executed safely, efficiently, and in accordance with all applicable codes and in accordance with Spark and Roche EHS Guidelines and Directives.
• Supports Asset lifecycle management and Asset Reliability programs.
• Leverage the Roche network for many areas of Engineering and Maintenance in accordance with guidance from the Head of Engineering Operations.
• Develop and Maintain Engineering Change Management Program inclusive of resources necessary to execute.
• Support and provide oversight as the Engineering representative(s) for the site Commissioning, Qualification and Validation (CQV) strategy, direction, and execution of CQV and related activities.
• Provide leadership and resource plans to support the site operational management.
• Effectively interface and provide support to Regulatory for authoring relevant sections of submissions and to Quality for deviation investigations, CAPAs and change controls. May serve as a liaison between Spark and the various governmental agencies/ regulators and external auditors.

Coordinate and cooperate Engineering, Metrology, Maintenance and Reliability teams to achieve business goals and objectives.

• Manage performance.   Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
• Develop team members.   Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential.  Understand your employee’s goals, strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
• Foster Spark’s Culture, Mission, Vision, and Values:  Lead by example.  Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.

Setting Strategy

• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty.
• Intellectual curiosity and dedication to science, innovation, and complex problem-solving.
• Commitment to corporate strategic priorities.

Executing for Results

• Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process.
• Sets aspirational goals to take organizational performance to the next level. Goes beyond conventional performance benchmarks to set world class best practice.
• Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization.

Leading Teams

• Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient”.
• Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and steps back to allow others to take action.
• Thoughtfully leads through influence. 

Building Relationships and Using Influence

• Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual.
• Works side-by-side with other leaders both internal and external to the Technology Organization and is respective of their departmental goals and how they impact the project. Influences and ensures alignment toward common priorities.
• Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Spark.

Education and Experience Requirements

• A minimum of 15-20 years of experience in progressively more responsible leadership positions in Facilities or Engineering in FDA regulated organizations, including 10+ yrs of Engineering Leadership supporting a Commercial Manufacturing Facility
• Advanced Degree (preferred) in Biological Sciences, Engineering, or related field

Key Skills, Abilities, and Competencies

• Must have direct experience/involvement in Regulatory inspections (multi-authority)
• Must have direct experience authoring relevant sections of Regulatory submissions and responding related to Information Requests
• Strong knowledge of GXP compliance as well as USP, EP, ICH and FDA guidelines
• Demonstrated ability to successfully manage multiple projects with delivery of timely and quality results

Complexity and Problem Solving

• Works on complex problems in which analysis of situations or data requires and in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.  Ensures budgets, schedules, and performance requirements are met.
• Builds productive relationships internally and externally.
• Establishes operational objectives and assignments and is involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect
• Frequent contacts with equivalent level managers and vendors concerning projects, operational decisions, scheduling requirements, or contractual clarifications.  Conducts briefings and technical meetings for internal and external representatives.

Internal and External Contacts

• Equipment end-users (owners) including Technical Operations/Manufacturing, Technology Development, as well as corporate functions such as Corporate Facilities/IT, Finance, etc.

●    Frequent external contacts, such as service providers, vendors, supplier representative and building owners/management.

Other Job Requirements

• Minimal Travel Requirements
• Requirement to work some weekends and off hours, depending upon project schedules.

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Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location.  Accommodations may be made in accordance with applicable law.