Rey Del Valle
Kenosha,WI
Summary
Accomplished leader with a strong track record in engineering, maintenance, operations, and project management in regulated manufacturing industries. Demonstrated expertise in leading projects ranging from $1 million to $45 million, delivering impactful results. Strategic and purposeful leader who has contributed over $1 billion to the overall success of the business through efficient and effective operations.
Overview
24
24
years of professional experience
Work History
Critical Utilities Manager
Simtra Biopharma.
01.2024 - 11.2024
- Led the maintenance, repair, operations, and troubleshooting for the site's electrical systems, BMS, domestic water systems, clean steam, house steam, compressed air, HVAC, chiller, cooling systems, and WFI systems
- Hire and supervise subcontractors.
- Manage one supervisor and fifteen indirect reports.
- Managed and motivated employees to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
- Maintained a professional, organized, and safe environment for employees and patrons.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Maximized performance by monitoring daily activities and mentoring team members.
- Cross-trained existing employees to maximize team agility and performance.
- Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
- Improved safety procedures to create safe working conditions for workers.
Sr. Maintenance Manager
Akorn Operating LLC
07.2022 - 02.2023
- Led the calibration/maintenance/repair/operations and MRO for the site electrical systems, cleanroom environments; domestic water systems; clean steam, boilers/steam condensate systems, compressed dry air/pressure, HVAC, chiller, and cooling systems, and WFI systems
- Hire and supervise subcontractors
- Troubleshoot, keep, and repair autoclaves, vial washings, depyrogenation tunnels, lyophilizes, isolators, filling, capping, and packaging lines
- Manage fifteen direct reports
NPI Manager
ALKU
04.2021 - 04.2022
- Led new product introduction into the packaging areas through the development of project plans, project meeting, and action items, delegating tasks to team members, driving, or executing all deliverables on time, within budget, and to the satisfaction of management and internal customers
- Develop and document the project's change plans using SoltraQ
Eng. Project Manager
Catalent Pharmaceutical
03.2019 - 01.2020
- Defined engineering project scope for operation and utilities area
- Defined the project's deliverables and project plan using the stage-gate process
- Created the project charter, plan, and schedule, and lead project team meetings
- Develop SOR, BOD, DD, URS, CAR, SOR, RFP, RFQ, and bidding packages
- Executed or delegated tasks driving or all deliverables on time, within budget, and to the satisfaction of management and customers
- Assessed project risks and developed mitigation plans
- Prepared and executed Project Change Control and CAPA using SoltraQ
Project Manager
ALKU
08.2018 - 03.2019
- Led the new supplier qualification project plans, delegating tasks to team members, driving, or executing all deliverables on time, within budget, and to the satisfaction of management and internal/external customers
- Collected data and prepared to change control summary for the Human Factor file used for the qualification of a new Autoinjector
- Assessed project risks and developed mitigation plans
- Prepared and executed project change controls, charter, and schedule
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
Maintenance Manager
Vi-Jon
09.2017 - 03.2018
- Ensured the best maintenance condition for all the processing, filling, packaging, and utilities equipment
- Managed a team of forty-five subordinates, delegating correcting, preventive, and predictive maintenance
- Led spare parts room and ensured availability of critical spare
- Evaluated the manufacturing schedule and coordinated the time changeover
- Managed a $3MM maintenance budget
- Recruited, trained, and appraised new mechanics
- Increased line's OEE from 47-55% through the implementation of operator's training and line set up procedures
Production Manager
Nesher Pharmaceuticals
06.2016 - 02.2017
- Facilitated all solid dosage manufacturing and maintenance daily activities and programs within building
- Ensured products were compliant with FDA, EMEA, CFR, and internal standards
- Drove the installation and qualification of a second coater to support the corporate capacity increase strategy
- Led processing equipment maintenance schedule
- Increased building performance to plan from 73-93%; reduced Notice and Event (NOE) by 33%; increased coating capacity by 50%; ended the coating tablets erosion defects through optimization of coater operational parameters; and ended black speck on tablets through detail development and training of cleaning and set-up instruction
GM and Owner
Ceciliana Service Station Corp
08.2009 - 06.2016
- Plan the daily gas station operation and long-term growing planning
- Evaluated the products inventories and ensure product replenishment to the shelves
- Maintained gas station licenses up to date
- Oversaw and approved cash expending and funds allocations
- Recruited and trained new employees
- Plan and execute capital plan and building and equipment maintenance
- Increased sales volume and expanded business from $0 to $9 MM in a three-year period
Maintenance Manager
PepsiCo WWF
01.2010 - 10.2011
- Conducted regular inspection, maintenance, and repair of all plant's processing and packaging lines and facilities/utilities with the use of internal or contract resources
- Ensured proper working conditions of all utility systems for facility and managed a team of subordinates and delegated their work areas
- Ensured compliance with calibration and maintenance schedule
- Ensured compliance of all corporate policies and rules (OSHA, EPA, AIBA, FDA) while conducting maintenance functions
- Developed a critical spare stocks availability
- Managed plant sanitation and pest control programs and supplied compliant documentation for both
- Evaluated and recommended HACCP program improvement
- Prepared, administered a $3MM budget, and ensured adherence to both the departmental budget and the CAR budget
- Developed Maximo's departmental SOPs, job plans, job schedule, goals, KPIs and TPM, and lean maintenance goals
- Successfully passed AIBA and corporate audits
- Implemented 7.1 version of MAXIMO CMMS software
- Reached over 99% spare parts inventory accuracy
Senior Project Manager/Manufacturing Manager
Bristol-Myers Squibb
03.2001 - 12.2008
- Supervised the architecture and engineering teams in the development of Statement of Requirement (SOR), Basis of Design (BOD), Detail Design Development (DDD), and constructability plans for solid dosage building construction and renovation
- Supervised the engineering, construction, and validation teams during the project execution phase
- Influenced project cost and construction, and led the project schedule control, equipment specification, procurement, installation, commissioning, and qualification
- Managed team for equipment installation, requalification, and process revalidation for the new and renovated building
- Integrated the construction, corporate, and local teams to ensure prompt project execution, compliance with regulations, and proper budget management
- Led the process transfer and validation of new manufacturing pharmaceutical solid dosage processes to support the new corporate products launch plan
- Implemented potent compound containment technology on the site, allowing for further introduction of new products
- Prepared capital project presentations, CARs, and status reports for the project and communicated them to the plant and corporate management
- Managed the integration of the new equipment and instruments into the CMMS system
- Managed and eased all solid dosage manufacturing, packaging, and daily maintenance activities within the plant
- Ensured planning and execution of WO manufacturing equipment and building, as well as managed building maintenance with subcontractors
- Prepared and executed the operational and maintenance budget and ensured compliance
- Integrated the manufacturing and the plant teams supporting the introduction of new product launches or existing product transfers according to a corporate strategic plan
- Restructured the manufacturing organization by clarifying roles and responsibilities and aligning goals with KPIs
- It resulted in positive synergy between members
- Led continuous innovation and lean manufacturing teams in the initiatives to reduce the manufacturing cycle time of blockbuster products
- Developed and reviewed process standards, packaging standards, and BOMs for new and existing products
- Supervised plant housekeeping and maintenance to ensure plant compliance for corporate and regulatory audits
- Led the manufacturing product transfer activities of blockbuster products > $1BB
- Ensured that all SOPs were scripted, reviewed, and changed promptly
- Led manufacturing area inspections with regulatory agencies such as EMEA, FDA, OSHA, and EQB
- Supervised over 130 employees including supervisors, technical supports, engineers, operators, and maintenance technicians
- Analyzed plant manufacturing forecast and prepared and presented three-year plant planning in the corporate meeting
Education
Bachelor of Science - Chemical Engineering
Bachelor of Science - Chemical Engineering
University of Puerto Rico
Mayaguez, Puerto RicoSkills
- Effective Leadership Skills
- Business Acumen
- Effective Conflict Management
- Safety Enhancement
- Quality and Regulatory Compliance
- Supply Chain Efficiency
- Project Management Expertise
- Construction, Commissioning, and Qualification
- Equipment procurement and Installation
- Cost and Budgeting
- Process Optimization Skills
- Effective Problem Resolution
- Maintenance, Utilities, Facilities, and Reliability Management
- Asset and Vendor Management
- Plant’s Construction and Start-Up
- Technical Troubleshooting Skills
Languages
English
Full Professional
Spanish
Native or Bilingual
Timeline
Critical Utilities Manager
Simtra Biopharma.
01.2024 - 11.2024
Sr. Maintenance Manager
Akorn Operating LLC
07.2022 - 02.2023
NPI Manager
ALKU
04.2021 - 04.2022
Eng. Project Manager
Catalent Pharmaceutical
03.2019 - 01.2020
Project Manager
ALKU
08.2018 - 03.2019
Maintenance Manager
Vi-Jon
09.2017 - 03.2018
Production Manager
Nesher Pharmaceuticals
06.2016 - 02.2017
Maintenance Manager
PepsiCo WWF
01.2010 - 10.2011
GM and Owner
Ceciliana Service Station Corp
08.2009 - 06.2016
Senior Project Manager/Manufacturing Manager
Bristol-Myers Squibb
03.2001 - 12.2008
Bachelor of Science - Chemical Engineering
Bachelor of Science - Chemical Engineering
University of Puerto Rico
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