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Mariela Arroyo-Hernández

Quality & Technical Services Engineer

San Juan, PR

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A proven record of eight years of experience in pharmaceutical industry environment. Knowledge in Utilities Process Water (WFI/ USP), Pharmaceutical Manufacturing Utilities support, Investigation Reports, Change Controls, Deviations, Corrective and Preventive Actions, Project Schedule, Management of Construction Operations, and Commissioning & Validation (IQ, OQ and PQ). Experience in shut down projects, upgrade construction projects, equipment installation & qualification, and computer system validation. Lead project manager for new Filtration system for site's Potable Water operations, WWTP upgrade, Well Water installation management project and other small projects with management roles in new Incoming Sampling Room, and Sampling Room on offsite warehouse.

Work Experience

Quality & Technical Services Engineer

Covidien
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Ponce, PR
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2010 to 2010

2010 
• Responsible for the develop Risk Management Binder including: Process Map, Cause & Effect Matrix, Process Failure Mode & Effect Analysis and Control Plan for diverse endo-surgical, laparoscopic and endoscopic instruments. 
• Audited reviewed and approve of Change Control packages, Investigation reports, Validation Plans and Performance Qualifications related to endo-surgical products such as spacemakers (ballons) and ports. 
• Conduct meetings to compile all information from the manufacturing, technical, and quality areas to complete the Risk Management Binder 
• Provided technical support in resolving quality supplier and process issues related to pars conditions and online rejects. 
• Perform the Tubing Expander units validation activities for installation and operation 
• Develop the validation protocol for Tubing Expander equipments on manufacturing area. 
• Support with the Non Conformance Reports for manufacturing area within follow up and status for each one 
• Follow up, develop and resolve the investigations on Incoming Area for the assemble parts matters 
• Evaluate sampled materials on Incoming area and determine if proceed to a Non Conformance Report. 
• Active participation on Business Unit daily meetings and direct communication with materials and suppliers. 
• Evaluate supplier parts on Incoming Sampling area and develop investigations for vendors parts 
• Evaluate Re-work, Engineering Test Request, Complaints, Process Investigations and Change Controls

Validation Engineer

Abbott Biologic
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Barceloneta, PR, US
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2009 to 2009

2009 
• Responsible for management of field activities, including walk downs and follow-up for punch list completions. 
• Coordinate start-up activities for several equipment with clients and contract personnel 
• Support Preventive Maintenance with mechanics and HVAC technicians for start-up purposes. 
• Executed and assembled Project Commissioning packages 
• Perform the HVAC and Reheat Water Package units commissioning qualification activities for installation and operation protocols

Validation Engineer

Wyeth Consumer HealthCare
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Guayama, PR, US
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2008 to 2009

• Responsible for installation and operational qualification protocols development and execution for Manufacturing Environmental Conditions, Manufacturing Room Utilities, and Manufacturing Facilities. 
• Development of Commissioning & Qualification Protocols, validation and commissioning & qualification Reports. 
• Worked within the engineering department for the execution of validation protocols to assure the equipment qualification and installation. 
• Active participation in the project meetings.

Project Engineer

McNeil Healthcare LLC
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Las Piedras, PR, US
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2007 to 2008

Responsible for directing and coordinating all activities for up front scope definition, equipment lay-out, design, estimate, construction, start-up, validation (IQ, OQ, PQ), and turnover. Develop budget estimating, and capital request appropriation submitted and presented to corporate level for endorsement. Coordinated construction contractor management, overall project execution, schedule and quality responsibility and complete project concept development through site. Developed Job Hazard Analysis, Risk and Environmental Assessment for all construction activities and safety permit approvals and closure on daily basis. Prepare weekly and daily construction progress reports. Coordination of A/E, C/M personnel and internal project staff both on-site and off-site were key aspect of on time and on budget completion. Most of these projects were fast track and coordination of research; process, estimating, design, cost and schedule support, construction and production activities were extremely critical. Manage bidding process for Capital project (general construction and equipments) and kick-off meetings. Project Plan development and projects progress status report and presentations on bi-weekly basis. 
List of Significant Projects: • New $1.6 MM Potable Water System Upgrade - Construction of two tanks (one underground and a 120,000gal) and new Filtration Room facility and equipments, excavation for new & existing piping installation. Potable Water System operational training (monitoring, back-up system and HMI) 
• New $1.2 MM Waste Water Treatment Plant Upgrade - Construction of additional tank, lift stations, and installation of new process equipments and controls. Manage project assigned budget to completed project. 
• New $200K Well Water Installation - Construction of additional Well Water and connection to the existing water underground tank 
• New $200K Outside Warehouse Sampling Booth - Installation of sampling booth and utilities 
• Utilities System Remediation Project - Assessment and recommendations for leaks and losses (monthly and year basis) of Steam and Compressed Air utilities through the site. Auditory of utilities systems.

Validation Engineer

Janssen Ortho
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Gurabo, PR, US
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2006 to 2007

• Responsible installation and operational qualification protocols development and execution for Air Handling Units, Reheat Coils, and Manufacturing and Storage Facilities. 
• Development of Commissioning & Qualification Protocols, validation documents, Impact Assessments, Validation Plan, Design Specification, Reports, User Requirement Specifications. 
• Developed a Computerized System Validation for an Air Handling unit protocol. Worked in coordination with engineering department for the execution of validation protocols to assure the equipment qualification and installation. 
• Participated on several packaging validations activities. 
• Developed of Change Request for several project

Project Engineer

Bristol Myers Squibb
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Humacao, PR, US
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2006 to 2006

2006 
• Responsible for management of construction operations, including contractor supervision, related to all project mechanical aspects including: HVAC, clean and plant utilities, fire protection systems, and selective equipment demolition and installation activities. 
• Assisted in procurement efforts including bid processes, bid evaluation, contract award, the development of requisitions, change requests and field requests with all their related and support documentation. 
• Coordinate construction activities and safety permit approvals on daily basis. Prepare weekly and daily construction progress reports. 
• Coordinate and perform construction inspections with client team, design engineers and construction personnel. 
• Supervise and audit HVAC duct leak tests, piping pressure tests and HVAC air and water systems balancing. 
• Coordinate shut-downs, tie-ins and project specific implementations with client's manufacturing liaisons as part of construction activities. 
• Manage design modifications to accommodate existing field conditions.

Project Engineer

Barry Wehmiller Design Group
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San Juan, PR
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2006 to 2006

2006 
• Prepared URS for Case packer and Palletizer machines and associated documents. 
• Developed overall scope documents and master schedule for Packaging Lines Construction project. 
• Prepared and assembled Project Commissioning Qualification Plan (PCQP), Commissioning and Qualification 
(C & Q) and Turn Over Package (TOP).

Quality & Compliance Engineer

Pfizer Pharmaceuticals LLC
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Barceloneta, PR, US
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2004 to 2006

• Administered the Corrective Action and Preventive Action (CAPA) program of engineering department, this included the tracking and expediting of action items in the utilities, maintenance, project and compliance teams , Quality Operations (QO) and production areas (API and Pharmaceutical operations) 
• Tracked engineering compliance incidents and deviations along with engineering related issues identified in audits from other areas (i.e. EHS, Security, Logistics, Finance, etc.) 
• Prepared, submitted and expedited approval of Change Control packages related to all engineering areas. Tracked associated field work as per engineering compliance requirements. 
• Prepared Position Papers with supporting data for investigation reports. 
• Conducted Incident and Deviation investigations with the intent of determining root causes and corrective / preventive actions. 
• Participated and provided support in internal and external audits. 
• Participated in the Critical Utilities Committee to present utilities-manufacture related projects previous to its development, for overall equipment shutdowns, manufacturing "windows" and samplings schedules coordination necessary to prevent project extensions or failures and the Site Quality Review Team to establish in utilities area the Pfizer Quality Standards through projects. 
• Conducted internal compliance assessments 
• Provided technical support in resolving quality issues 
• Audited and reviewed Turn Over Packages (TOP) for Commissioning & Qualification activities. 
• Prepared reports and action plans, and identified projects related to Pfizer Quality Standards (PQS) 
• Reviewed regulatory requirements (EHS, cGMPs, PQSs) and trained engineering department personnel. 
• Enforced and reviewed overall compliance with local and federal regulations, company policies and procedures pertaining to OSHA, EEO, FDA, DEA, environmental and other regulatory agencies.

Utilities Supervisor

Pfizer Pharmaceuticals LLC
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Barceloneta, PR, US
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2002 to 2004

• Responsible for operation of all utility services and associated equipment required in supporting plant-wide production operations (API and Dry Product Facilities including Aseptic Filling areas) 
• Supervision of all engineering related plant issues (maintenance and utilities) during after-hour shifts. 
• Responsible for personnel supervision, equipment monitoring and attendance to Pharmaceutical and API manufacturing areas daily production meetings and information / work distribution to utilities area operators and support teams. 
• Responsible for the preparation and maintenance of utilities area SOPs. 
• Development of safety incident reports and action plan implementation to correct safety incident causes. 
• Developed daily status reports for all critical areas, including API, Pharmaceutical and Utilities Areas to be distributed to site management for follow up areas and equipment monitoring and condition. 
• Responsible for daily support and coordination with construction contractors and projects related to the utilities area. 
• Ensured compliance of shift operations with local and federal regulations as well as company policies. 
• Responsible for troubleshooting of utilities equipment and related process improvements. 
• Executed strategies and action plans to support plant supply chain goals and objectives. 
• Administered Pfizer Business Continuity Plan for Utilities area to provide different alternatives for site's continuous operations.

Manufacturing Project Engineer

Pfizer
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Guayama
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June 2011

• Project Management in transfer manufacturing laboratory equipment inter-site 
• Coordinate within all departments support for the equipment relocation and evaluate the impact on equipment final location. 
• Generate Change Controls, Calibration and Preventive Maintenance related documentation  
• Route all related document on a timely fast track period 
• Follow up different departments involved in the Change Control for on-time implementation

Manufacturing Project Engineer

Pfizer
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Guayama
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June 2011

• Project Management in transfer manufacturing laboratory equipment inter-site 
• Coordinate within all departments support for the equipment relocation and evaluate the impact on equipment final location. 
• Generate Change Controls, Calibration and Preventive Maintenance related documentation  
• Route all related document on a timely fast track period 
• Follow up different departments involved in the Change Control for on-time implementation

Manufacturign Project Engineer

Pfizer
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Guayama

• Project Management in transfer manufacturing laboratory equipment inter-site 
• Coordinate within all departments support for the equipment relocation and evaluate the impact on equipment final location. 
• Generate Change Controls, Calibration and Preventive Maintenance related documentation  
• Route all related document on a timely fast track period 
• Follow up different departments involved in the Change Control for on-time implementation

Manufacturing Project Engineer

Pfizer
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Guayama

• Project Management in transfer manufacturing laboratory equipment inter-site 
• Coordinate within all departments support for the equipment relocation and evaluate the impact on equipment final location. 
• Generate Change Controls, Calibration and Preventive Maintenance related documentation  
• Route all related document on a timely fast track period 
• Follow up different departments involved in the Change Control for on-time implementation

Education

M.B.A. in Technology Management

Phoenix University -
Guaynabo Campus

January 2007

B.S. Me in Mechanical Engineering

University of Puerto Rico -
Mayaguez Campus

January 2002

Additional Information

Technical Expertise 
Steam traps 
Compressed Air 
Project Management 
Potable Water Distribution System 
Waste Water Treatment Plant 
Validation 
Incident Reports 
Change Controls 
Well Water Distribution System 
Energy Management 
Capital Request Development 
 
Skills 
Manage multiple projects and priorities 
 
Take responsibility for and analyze tasks to achieve objectives and deadlines 
 
Excellent teamwork abilities, interpersonal and group motivation skills, self starter 
 
Communicate persuasively with technical and 
non-technical audiences 
 
IT Skills 
Microsoft Office 
Microsoft Project 
MathCAD 
Mat Lab 
Internet Search Engines 
Acrobat Reader 
AutoCAD 
Outlook 
Work orders & Spare parts