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Biopharmaceutical SENIOR COMMISSIONING & QUALIFICATION ENGINEER
ZipRecruiter, Boulder, Colorado, United States, 80301
Job Description
Salary:
Previous
Pharmaceutical/Biotech
experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, and Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, and Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies). This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities. The work will require working out of the clients' facilities. This role is for a Bioprocess C&Q Engineer to work on the commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor
intermediate/junior
engineers. Responsibilities Provide technical guidance into the commissioning, qualification, and start-up of various equipment and facilities. Lead the development of key qualification deliverables during the project lifecycle to ensure the project is well defined, and the action plan to test the system is applicable and relevant. Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met. Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports. Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, and facilities is an asset. Thermal Validation experience is an asset. Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates. Engage other departments, as required, for design reviews and decisions. Travel may be occasionally required for meetings with clients, equipment fabrication vendors, or Factory Acceptance Testing (FATs). Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases. Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers, etc. Visit construction and installation sites following all site safety requirements. Supervise contractors during critical testing of systems and equipment. Other duties as assigned by client and/or MMR based on workload and project requirements. Qualifications Excellent written and spoken English is required including the preparation of technical documents in English. Years of experience: 8+ years in commissioning, qualification, or validation of various systems within the
pharmaceutical/biotech
industry, where a minimum of 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems. Knowledge of requirements for cGMP operations, including SOPs, Change Controls, and Validation. Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required. Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required. Experience with commissioning & qualification of process control systems (i.e., PCS, SCADA, Historians) and building automation systems (i.e., Siemens Insight / Desigo, JCI Metasys) are considered an asset. Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset. Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports. Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, and help staff resolve issues. Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity. Ability to lift 50 lbs. Possess mentorship skills, to coach and develop junior and intermediate employees. Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline. Ability to handle multiple projects and work in a fast-paced environment. Strong multi-tasking skills. Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
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Pharmaceutical/Biotech
experience is mandatory for this role. MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, and Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, and Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies). This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning, and qualification of equipment, systems, and facilities. The work will require working out of the clients' facilities. This role is for a Bioprocess C&Q Engineer to work on the commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor
intermediate/junior
engineers. Responsibilities Provide technical guidance into the commissioning, qualification, and start-up of various equipment and facilities. Lead the development of key qualification deliverables during the project lifecycle to ensure the project is well defined, and the action plan to test the system is applicable and relevant. Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ, and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met. Prepare protocols, execute protocols, summarize data, resolve deviations, and prepare final reports. Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, and facilities is an asset. Thermal Validation experience is an asset. Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, and provide updates. Engage other departments, as required, for design reviews and decisions. Travel may be occasionally required for meetings with clients, equipment fabrication vendors, or Factory Acceptance Testing (FATs). Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning/validation phases. Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers, etc. Visit construction and installation sites following all site safety requirements. Supervise contractors during critical testing of systems and equipment. Other duties as assigned by client and/or MMR based on workload and project requirements. Qualifications Excellent written and spoken English is required including the preparation of technical documents in English. Years of experience: 8+ years in commissioning, qualification, or validation of various systems within the
pharmaceutical/biotech
industry, where a minimum of 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems. Knowledge of requirements for cGMP operations, including SOPs, Change Controls, and Validation. Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required. Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required. Experience with commissioning & qualification of process control systems (i.e., PCS, SCADA, Historians) and building automation systems (i.e., Siemens Insight / Desigo, JCI Metasys) are considered an asset. Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset. Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports. Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, and help staff resolve issues. Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity. Ability to lift 50 lbs. Possess mentorship skills, to coach and develop junior and intermediate employees. Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, or a related discipline. Ability to handle multiple projects and work in a fast-paced environment. Strong multi-tasking skills. Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
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