The Maintenance and Reliability Engineer is accountable for delivering maintenance excellence activities across assigned equipment, facilities and utility systems to deliver cost savings, energy reductions, improved uptime, and improved overall equipment and systems reliability. This role serves as the Technical Lead of the site Reliability and Total Productive Maintenance (TPM) processes. Executes/deliver the TPM strategy as per site goals targets. Serve as the System Owner for assigned systems, ensuring compliance with company policies, procedures, and all applicable regulations.

Acts in a leadership role in providing engineering support and technical expertise for GMP and non-GMP related equipment and utilities systems. This role will foster a reliability focused mindset where equipment and related systems downtime impact becomes part of the day-to-day decision making. By working closely with cross-functional team disciplines, this role will ensure that the iPR manufacturing operation is working towards executing in an efficient and effective way.

Plays a key role in supporting the strategy development, project/process improvements and representing the site on related regional or global forums.

The incumbent is responsible for leading and maintaining, as applicable, process improvement of the PET (Process Execution Team) Formulation Department, including digital systems/platforms such as: AZ-SHE System, SAP (Finance, Maintenance, Calibration), Asset Life Cycle Management, Site Master Plan, Department Scorecard, with all sub-systems related to collect the data, Key Performance Indicators, dashboards, SABA and others.

Lean Champion for the PET Formulation, promoting a continuous improvement culture. Works with the implementation and monitoring of projects/process improvements, including the development of Business Cases (benefit, return on investment, impact, etc).

This role serves as the Maintenance Facilitator for the PET.

Typical Accountabilities

System Ownership: Deliver maintenance excellence across assigned systems and serve as systems Subject Matter Expert (SME).
Regulatory Compliance: Interface with Regulatory Agencies and Internal AZ Auditors, understanding and ownership of applicable inspection deliverables.
Reliability-Centered Maintenance (RCM): Lead and maintain the RCM program, including all testing, monitoring, and analysis of assets to determine and implement appropriate preventive and predictive maintenance programs, minimizing equipment down time and enhancing overall asset performance.
Preventive Maintenance (PM): Responsible for Preventive maintenance, including work scheduled based on predictive analysis and documented job steps to prevent business disruption.
Reliability Strategies: Provide reliability strategies, training, and tools for maintenance and operation organizations to maximize the availability of all assets; develop and maintain a rolling plan for all assets.
Root Cause Analyses: Perform documented Root Cause Analyses and Failure Modes and Effects Analyses (FMEA), aiming agile issue resolution preventing recurrence.
Predictive Maintenance Technologies: Provide and manage support for predictive maintenance technologies such as IR Thermography, Oil Analysis, Vibration Analysis, and Ultrasonic Analysis.
Equipment Criticality: Establish equipment criticality ranking and apply PM and PdM tools to critical equipment; eliminate or adjust scheduled PM activities based on PdM information.
Spare Part Management: Lead teams to establish spare part criticality matrix and ensure inventory levels are determined through reliability efforts, keeping a balanced approach between availability and inventory.
Capital Projects: Interface with capital and expense projects to engineer reliability on the design and operation/repair of the facility, utilities and equipment.
Budgeting: Provide maintenance plans and information for annual budgeting. Supports department cost monitoring process (budget, RBU, accruals, etc.) vs. plan monthly and drives budget spend adherence. Prepare consolidated annual budget, RBU's and MTP forecast, including financial cost monitoring adherence monthly for expenditure and capital revenue for all BUs of Engineering Department.
Asset Management: Business Process Owner for asset management for assigned assets, collaborating with Finance and other departments to ensure asset register is maintained and obsolete assets are inventoried, assessed, written-off, and disposed in accordance with applicable procedures.
PM Program Optimization: Optimize PM program including creation, scheduling frequency, and Condition-Based Maintenance Program seeking for opportunities (i.e. frequency, scope) based on demand and utilization.
Failure Analysis: Conduct failure analyses to identify improvement opportunities.
Training and Development: Support in ensuring technical training plans is in place and implemented for mechanics and technicians for assigned systems and capital projects, optimizing resources capability and flexibility.
Support the PET Site Strategy development and project planning for the site (e.g. 5-yearplan), including areas for LTO, innovation, process improvements, resources planning and business cases justification.
Coordinate and lead department meetings and/or Kaizen events that drive process improvements.
Consult/collaborate with internal and external networks (i.e. industry experts) to identify benchmarks and innovative technologies to achieve equipment reliability goals/targets.
Lead the TPM strategy as per site goals targets.
Collaborate with other groups and functions establishing relationships and influencing with key business stakeholders to ensure alignment with project/programs objectives.
Prepares presentation for management reports and implement online management reports on key performance parameters.
Play a key role on the Asset Life Cycle Management (ALCM) program for the site, including prioritization as per 5-year strategy with main objective to reduce or eliminate them from site Risk register.

Education, Qualifications, Skills and Experience

Essential

Education/Experience:

Bachelor's degree in mechanical or electrical Engineering with a minimum of six (6) years related experience and/or training. Thorough knowledge of the pharmaceutical/medical device industry with emphasis in manufacturing, packaging, utilities, and related equipment (including automation). Project management experience and proficiency required. Knowledge and understanding of validation and qualification principles, project management, and change control principles. Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment.

Language:

Fully Bilingual (English and Spanish)

Ability to read, analyze, and interpret general business (Business acumen), professional industry trend, including SHE area /technical/GMP and government regulations. Ability to write business case project proposals, plans, budgets and relate project documents. Ability to write technical (both high and low level) specifications, procedures, plan, and reports. Ability to effectively present technical information and respond to questions from group of peers, managers, and customers/stakeholders.

Digital Literacy:

Working knowledge of MS Windows Operating Systems. Windows applications such as Word, Excel, Access, Power Point and Project, among others. Working knowledge on SAP, and GVLMS.

Desirable

Professional Engineer (PR) License preferred.
Experience in the pharmaceutical or biotechnology industry is desired.
Lean Six Sigma certification preferred.
Asset Management or Reliability certification preferred.

Why iPR Pharmaceuticals?

At iPR Pharmaceuticals we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and fuel your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. A culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

iPR Pharmaceuticals embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

31-Oct-2024

Closing Date

17-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.