ANDRES PANTOJA CONCEPCION
Natick,MA
Summary
Innovative problem solver with over a decade of experience in the pharmaceutical and biotech industries, looking for a new challenge. Has demonstrated the capacity to do any assignment efficiently and with little to no supervision in a cross-functional team setting. Independent thinker committed to improving the drive, work ethic, and function of an engineering team through direct involvement.
Overview
14
14
years of professional experience
Work History
Facilities Operations Supervisor
FUJIFILM Diosynth Biotechnologies
11.2023 - Current
- I oversaw and supervised day-to-day maintenance tasks, such as inventory control, work order processing, CCMS/CMMS administration, and maintenance and calibration duties.
- Supervised maintenance support operations in biotechnology facility to ensure compliance with cGMPs and SOPs
- Promote efficient cooperation amongst various departments—manufacturing, engineering, maintenance and calibration, quality assurance, and outside suppliers—to guarantee that tasks related to maintenance operations are completed with outstanding quality.
- Make sure that departmental goals and objectives are fulfilled while staying within approved spending limits and schedules.
- Coordinated with vendors and contractors to arrange services and repairs to be completed on time and to desired quality levels.
- Supervised staff of 4 in day-to-day activities.
Metrology & Maintenance Manager
IVexSol Inc.
05.2023 - 10.2023
- Created and implemented calibration procedures and protocols in accordance with existing industry norms, allowing company to expand while adhering to regulatory constraints
- Maintained day-to-day facility operations, such as delegating and performing repair and maintenance orders
- Supported validation and qualification processes for cGMP systems and equipment
- Prepared reports on maintenance, repairs, safety, and other incidents for supervisors and other appropriate personnel.
- Collaborated with other department managers to coordinate maintenance activities around production schedules, minimizing operational interruptions.
Sr. Metrology & Validation Manager
Lykan Bioscience
10.2019 - 04.2023
- Lead team of service engineers in troubleshooting and fixing equipment problems, performing preventative maintenance, and implementing adjustments and improvements
- Developed and executed validation and calibration policies and procedures aligned with regulations and industry standards to support organizational growth and compliance
- Assisted with Commissioning Qualification Validation (CQV) and Environmental Monitoring Performance Qualification
- Coordinated client equipment requirements with vendors, consultants, and suppliers to ensure project completion on schedule, within scope, and within budget
- Coordinated with departmental management to ensure that invasive validation and metrology activities are carried out in accordance with approved protocols so as not to disrupt scheduled production
- Collaborated with Capital Projects and Facilities—Plant Maintenance on capacity expansion needs, when appropriate
- Prepared reports on maintenance, repairs, safety, and other incidents for supervisors and other pertinent personnel.
- Cross-trained existing employees to maximize team agility and performance.
- Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.
Sr. Metrology Technician
Audentes Therapeutics
02.2019 - 10.2019
- Prepared equipment documentation and calibration procedures to ensure equipment is maintained in line with applicable regulatory agency validation criteria, internal corporate standards, and industry norms
- Investigated and implemented ideas for quality improvements, increased productivity and cost reduction
- Compiled calibration data to make recommendations for changes and/or improvements
- Investigate and troubleshoot problems that occurred and recommend solutions
- Supported in developing specifications for instrumentation and calibration standards.
Metrology Specialist & Validation Technician
Dendreon Pharmaceuticals
10.2012 - 02.2019
- Managed, mentored, trained and provided guidance to metrology team.
- Earned recognition as top performer consistently exceeding targets throughout my tenure as specialist.
- Prepared equipment documentation and calibration procedures to ensure equipment is maintained in accordance with appropriate regulatory agency validation requirements, internal company standards and current industry practices.
- Executed calibration activities for cGMP equipment and systems.
- Investigated and implemented ideas for quality improvements, increased productivity, and cost reduction.
- Performed validation execution of on-site temperature-controlled chambers, ensuring validation processes meet regulatory requirements (IQ, OQ, and PQ)
- Compiled calibration data to make recommendations for changes and/or improvements.
- Investigate and troubleshoot problems that occur and recommend solutions.
- Supported in developing specifications for instrumentation and calibration standards.
- Participated in development, implementation, and adherence to standard operating procedures.
- Participated in development and implementation of internal validation policies (equipment, utilities, cleaning, and processes), ensuring processes and systems meet regulatory requirements.
- Maintained calibration documents for database and approved protocols and final reports (IQ, OQ, and PQ)
Sr. Manufacturing Associate I
Dendreon Pharmaceuticals
07.2010 - 10.2012
Manufacturing Technician
Shire HGT
01.2010 - 07.2010
Education
Skills
- Familiarity with calibration requirements (NIST, ISO9001/IEC 17025, etc)
- Technical expertise in the operation and maintenance of process equipment
- Good understanding of various metering and measuring equipment
- Resources Coordination, Scheduling & Budget Management
- Familiarize with FDA and GMP regulations
- Familiarize with cGMP ISO 5, 7 & 8 classes
- Proficient with ISO 5, 7 & 8 Gowning
- Aseptic Process Validation and execution
- Validation: (Equipment IQ, OQ, PQ & Building CQV)
- Room Certification
- SME, in use of GE/Kaye Validator, Lives
- Computerized Maintenance Management System Administration (SME)
- Quality Management System
- Security management
- Building Automation Systems
- Budget Administration
- Planning and scheduling
- Leadership and supervision
Languages
Spanish
Professional Working
Timeline
Facilities Operations Supervisor
FUJIFILM Diosynth Biotechnologies
11.2023 - Current
Metrology & Maintenance Manager
IVexSol Inc.
05.2023 - 10.2023
Sr. Metrology & Validation Manager
Lykan Bioscience
10.2019 - 04.2023
Sr. Metrology Technician
Audentes Therapeutics
02.2019 - 10.2019
Metrology Specialist & Validation Technician
Dendreon Pharmaceuticals
10.2012 - 02.2019
Sr. Manufacturing Associate I
Dendreon Pharmaceuticals
07.2010 - 10.2012
Manufacturing Technician
Shire HGT
01.2010 - 07.2010