...Description:
The Associate Technical Engineering will provide automation support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that supported areas and activities are maintained in compliance with respect to current...
...Engineering and 5 years of Engineering experience.
Preferred Qualifications:
Experience in Parenteral Inspection and/or Packaging equipment.
Knowledge in Engineering Project.
Experience in Medical Device or Pharma.
Knowledge in CAPA, Change Management and...
..., resolución de problemas y documentación de instrumentos, sistemas de control de procesos y equipos utilizados en la fabricación, plantas de servicios públicos y laboratorios analíticos. Para aplicar, visite nuestra página web o envíe su resume a ******:Grado asociado...
...and documentation of instruments, process control systems, and equipment used in manufacturing, utility plants, and analytical labs.... ...controllers.
Basic troubleshooting and repair of process control and laboratory instruments. All work must be completed in accordance with...
...participating in validation projects relating to biopharmaceutical and pharmaceutical manufacturing equipment, critical computer systems, manufacturing processes, and laboratory documentation for a Biotechnology located in Norwood, Massachusetts for a 6-month contract....
...processes.
Duties:
Validation and documentation processes in a highly regulated environment.
Operate specialized laboratory equipment and computers as appropriate.
Interpret and apply GLPs and GMPs.
Apply a science-based approach to production.
Development...
...goal.
5. Monitor and communicate incidents trends.
6. Review equipment/system Root Cause Analysis investigations and support trend... ...basic compliance discrepancies
• Knowledge in Validations and Laboratory area and equipment
• Strong organizational skills, including...
...and documentation of instruments, process control systems, and equipment used in manufacturing, utility plants, and analytical labs.... ...7. Basic troubleshooting and repair of process control and laboratory instruments.
8. All work must be completed in accordance with...
...Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.
Applies advanced and diverse validation...
...approval as QA contact
• Work with operations to resolve basic compliance discrepancies
• Knowledge in Validations and Laboratory area and equipment
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...Preferred:
~Experience in Industrial Utilities Generation equipment
~Maximo application
~Spare parts management
~Equipment reliability...
...services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the... ...or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.
~ Able...
...Familiarity with validation and documentation processes in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply science based...
...Familiarity with validation and documentation processes in a highly regulated environment.
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs.
Ability to apply science based approach to...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...Qualifications:
~Working knowledge of pharmaceutical/biotech equipment.
~Basic skills (Personal organization, English/Spanish...
...Operations Engineering: 1. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become... ...highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...Manufacturing, Isolators
~Advanced validation knowledge (equipment qualification, cleaning, sterilization).
~Applies extensive technical...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...Operations Engineering:
#Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...variables.
~Knowledge in Pharmaceutical and Biotechnology equipment.
~Knowledge of GXP for Pharmaceuticals, Biotechnology, and Medical...
...Familiarity with validation and documentation processes in a highly regulated environment.
~ Ability to operate specialized laboratory equipment and computers as appropriate.
~ Ability to interpret and apply GLPs and GMPs.
~ Ability to apply science-based approach...
...services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the... ...highly regulated environment
~Ability to operate specialized laboratory equipment and computers as appropriate.? Ability to interpret...
...Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment.
Responsibilities:
Able to...
...more than one area of engineering (process, unit operations, and equipment project) in complex process characterization, optimization,... ...a highly regulated environment Ability to operate specialized laboratory equipment and computers as appropriate. Ability to interpret and...
...improvements.
Maintain instrumentation and equipment preventative maintenance and supporting... ...initiation of Deviations, CAPAs, and Laboratory Investigations, as required by the... ...holidays).
Require working in and around laboratories and controlled, enclosed, restricted...
...subject matter expert for the Process Development Drug Product Laboratory Operations area
WHAT MAKES YOU A FIT:
The Technical Part... ...skills.
Use of stereomicroscopes, calipers, X-Ray/CT Scan Equipment, etc.
The Personality Part:
~ Picture yourself in a...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...pharmaceutical/biotech production processes, facilities, and equipment.
~Working knowledge and experience with Quality Risk...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...performance and regulatory compliance of a limited number of equipment items or systems of minor to moderate complexity.
~Routinely...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...problems.
~Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
~Collaborate with stakeholders to assess...
...Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation... ...:
~Experience in Parenteral Inspection and/or Packaging equipment.
~Knowledge in Engineering Project.
~Experience in Medical Device...