JMD Technologies Inc.
Validation Engineer (aseptic process simulations)
JMD Technologies Inc., Boston, Massachusetts, us, 02298
Overview
Validation Engineer (aseptic process simulations) experience in CQV for Analytical Instrumentation and Manufacturing equipment. aseptic process simulations (APS) Responsibilities
Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of Analytical Instrument and Manufacturing equipment. Support all stages of qualification of automated manufacturing equipment Conduct Analytical Instrumentation Qualifications in accordance with USP Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes Vertex assigned training and ensures that they are
100% compliant 100% of the time . Ensure that all Validation activities align with the current Vertex SOPs, global standards and cGMP guidelines. Supports
right-the-first time
culture for all documents distributed across the organization. Ensure the VCGT Validation team
reputation and partnership
is flourished with the cross-functional teams. Qualifications
Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment. Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas. Receptive to change – Adapts (quickly) to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Validation Engineer (aseptic process simulations) experience in CQV for Analytical Instrumentation and Manufacturing equipment. aseptic process simulations (APS) Responsibilities
Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of Analytical Instrument and Manufacturing equipment. Support all stages of qualification of automated manufacturing equipment Conduct Analytical Instrumentation Qualifications in accordance with USP Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes Vertex assigned training and ensures that they are
100% compliant 100% of the time . Ensure that all Validation activities align with the current Vertex SOPs, global standards and cGMP guidelines. Supports
right-the-first time
culture for all documents distributed across the organization. Ensure the VCGT Validation team
reputation and partnership
is flourished with the cross-functional teams. Qualifications
Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment. Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas. Receptive to change – Adapts (quickly) to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr