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Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.
DESCRIPTION
Under limited supervision support process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
EDUCATION
Bachelor’s degree in Engineering (Chemical or Mechanical) and 2-4 years of Engineering experience
PREFERRED QUALIFICATIONS:
• 2-4 years of experience with bulk pharmaceutical operations equipment is required.
• Excellent technical and quality documentation skills in English.
• Experience and knowledge of Fermentation processes is preferred.
• Computer systems validation experience in regulated operations (preferably GMP operations).
• Able to use a logical, systematic approach to problem solving.
• Ability to manage multiple projects and prioritize work based on business needs.
• Strong communication, teamwork and collaboration skills.
• Available to work or provide support to a 24/7 operation.
RESPONSIBILITIES
Ultimate Solutions Corp is an Equal Opportunity Employer
Pilot Plant Engineer
Puerto Rico, PRUltimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.
DESCRIPTION
Under limited supervision support process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
EDUCATION
Bachelor’s degree in Engineering (Chemical or Mechanical) and 2-4 years of Engineering experience
PREFERRED QUALIFICATIONS:
• 2-4 years of experience with bulk pharmaceutical operations equipment is required.
• Excellent technical and quality documentation skills in English.
• Experience and knowledge of Fermentation processes is preferred.
• Computer systems validation experience in regulated operations (preferably GMP operations).
• Able to use a logical, systematic approach to problem solving.
• Ability to manage multiple projects and prioritize work based on business needs.
• Strong communication, teamwork and collaboration skills.
• Available to work or provide support to a 24/7 operation.
RESPONSIBILITIES
• Understand the basic scientific and engineering principles required for fermentation manufacturing processes.
• Understand how process requirements, as established in operational instructions, procedures, process flow documents, etc. translate into field execution.
• Review production instructions and serves as the co-owner in the preparation, revision and approval of operational instructions.
• Provide technical support for the operational troubleshooting and implementation of identified countermeasures.
• Perform tasks related to fermentation process (i .e. discharge tanks, material handling, raw material charges, equipment cleaning, in-process testing, etc. )
• Provide support to the management of daily operations, including 24hr/7days technical support
• Attend and participate in Process Team meetings/Weekly
• Have understanding of operational control strategy and how the equipment impacts key process parameters.
• Lead/Support execution and technical documentation related to Equipment related Events, Corrective Actions Preventive Actions (CAPAs) and Changes, as applicable.
• Provide technical expertise for installation, operation, maintenance, and reliability of pilot plant process equipment.
• Have holistic understanding of Process Validation (and associated equipment, facilities, and computer systems), assessment of significant changes, maintenance and other interventions, involvement with Preventive Maintenance (PM) Plans and spare parts list. Assist in preparation of verification documents, participate in the execution of the activities, and support the approval.
• Makes decisions within guidelines and policies and ensures compliance with all requirements, policies, and regulations.
• Ensure safety processes (procedures, training, and equipment) are in place (i.e., Lockout/Tag Out [LOTO], Line breaking, etc.) for pilot plant activities.
• Understand how process requirements, as established in operational instructions, procedures, process flow documents, etc. translate into field execution.
• Review production instructions and serves as the co-owner in the preparation, revision and approval of operational instructions.
• Provide technical support for the operational troubleshooting and implementation of identified countermeasures.
• Perform tasks related to fermentation process (i .e. discharge tanks, material handling, raw material charges, equipment cleaning, in-process testing, etc. )
• Provide support to the management of daily operations, including 24hr/7days technical support
• Attend and participate in Process Team meetings/Weekly
• Have understanding of operational control strategy and how the equipment impacts key process parameters.
• Lead/Support execution and technical documentation related to Equipment related Events, Corrective Actions Preventive Actions (CAPAs) and Changes, as applicable.
• Provide technical expertise for installation, operation, maintenance, and reliability of pilot plant process equipment.
• Have holistic understanding of Process Validation (and associated equipment, facilities, and computer systems), assessment of significant changes, maintenance and other interventions, involvement with Preventive Maintenance (PM) Plans and spare parts list. Assist in preparation of verification documents, participate in the execution of the activities, and support the approval.
• Makes decisions within guidelines and policies and ensures compliance with all requirements, policies, and regulations.
• Ensure safety processes (procedures, training, and equipment) are in place (i.e., Lockout/Tag Out [LOTO], Line breaking, etc.) for pilot plant activities.
Ultimate Solutions Corp is an Equal Opportunity Employer