Validation\Packaging Specialist Thermo Fisher Scientific – Rockville, MD
This position is responsible for Creating, analyzing packaging that meet cost, quality, lead time, customer and regulatory requirements. For creating, transit testing protocols to qualify the effectiveness of packaging. Collaborate Operations, Quality and other internal departments to represent and complete client packaging qualifications. This position also requires validation testing, troubleshooting, calibration/ certification of storage units, devices and temperature monitoring probes.
This position ensures that all instruments are in a qualified state. This position requires participation in environmental engineering studies, use programs/applications to collect and evaluate temperature with the scope for travel as needed to client and offsites as the subject matter experts (SME’s). The instrumentation equipment works at temperatures ranging from ambient (room temperature) to below freezing. This position uses database applications and standard precautionary procedures to work independently, be self-directed, communicate effectively, and use good judgment when making decisions. Internal or external client interaction occurs under the guidance of experienced professional or technical staff.
Essential Duties and Responsibilities:
Validation Engineer 2 (Validation/ Packaging Specialist)duties:
Creating testing protocols to analyze packaging that meet cost, quality, lead time, customer and regulatory requirements.
Creating transit studies to validate the effectiveness of the packaging through practical and industry accepted methods.
Collaborate with Operations, Quality Engineering, Sustaining Engineering and customer represented departments to resolve packaging issues related to freight damage.
Responsible for performing qualification/validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
Must design, develop protocols for testing while being able to modify SOP’s, SWI’s related to validation/qualification processes, protocols, reports and procedures as the subject matter expert(SME).
Develop and execute cold chain engineering studies geared towards client specific and internal FBS projects.
Participate, facilitate and/or support validation training and project management activities as required.
Maintains all documentation pertaining to validation
Coordinates assigned projects and represents department on qualification projects.
Serves as an information resource to contractors and vendors.
Coordinates assigned projects and represents department on project teams.
Participate in process improvement activities.
Assure compliance to cGMP parts 210 and 211 and company quality systems.
Follow standard operating procedures (SOPs), facility safety guidelines, and Food & Drug Administration (FDA) requirements which may include compliance with cGMP CFR parts 210 and 211 where applicable.
May be required to travel to other facilities to meet business needs.
Other duties may be assigned to meet business needs.
Basic Minimum Qualifications: The qualifications listed below are representative of knowledge, skill and/or ability. To perform this job successfully, an individual must be able to complete each essential duty.
Requires ability to communicate effectively verbally and in written form.
Ability to prepare reports using Excel; knowledge of Windows, Word and Access preferred.
Knowledge of Universal Precautions, general laboratory and quality assurance/control preferred.
Valid driver’s license and good driving record if required to travel to other locations.
Bachelors degree in Engineering/life science field preferred.
Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries preferred.
Prefer experience with Current Good Manufacturing Practices (cGMP).
Prefer ability to perform NIST traceable temperature and humidity measurements with a variety of temp/humidity measurement devices.
Prefer Validation experience with Cleaning Validation; Equipment Validation; Critical Utility Systems Temperature Mapping/ Kaye Validation platform/ Controlled Temperature Units/ Freezers/Data Loggers.
Prefer Qualification experience with IQ/OQ/PQ protocol development/writing/execution; G& Facilities; Utilities/HVAC; Process Equipment; Final Reports.