MMR Consulting
BiopharmaceuticalCOMMISSIONING & QUALIFICATION ENGINEER
MMR Consulting, San Diego, California, United States, 92189
Biopharmaceutical COMMISSIONING & QUALIFICATION ENGINEER
Biopharmaceutical COMMISSIONING & QUALIFICATION ENGINEER
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by MMR Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$70,000.00/yr - $120,000.00/yr 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, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, 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 client’s facilities. This role is for Bioprocess C&Q Engineer role to work on the commissioning, qualification, 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 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. Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset. Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, 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. 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: 5+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry. Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, 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 URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports. Ability to lift 50 lbs. 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. Salary range: 70,000$ -120,000$ based on experience. Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity 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 or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request. Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Manufacturing Referrals increase your chances of interviewing at MMR Consulting by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Pension plan Get notified about new Qualification Engineer jobs in
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Tijuana, Baja California, Mexico 21 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Biopharmaceutical COMMISSIONING & QUALIFICATION ENGINEER
1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by MMR Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$70,000.00/yr - $120,000.00/yr 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, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, 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 client’s facilities. This role is for Bioprocess C&Q Engineer role to work on the commissioning, qualification, 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 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. Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset. Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, 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. 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: 5+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry. Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, 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 URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports. Ability to lift 50 lbs. 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. Salary range: 70,000$ -120,000$ based on experience. Equal Employment Opportunity and Reasonable Accommodations MMR Consulting is an equal opportunity employer. We celebrate diversity 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 or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request. Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Manufacturing Referrals increase your chances of interviewing at MMR Consulting by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Pension plan Get notified about new Qualification Engineer jobs in
San Diego, CA . Commissioning, Qualification & Validation Engineer
Engineer, Manufacturing Test Engineering
Principal Engineer of Gas Turbine Aerodynamics
Hardware Compliance & Manufacturing Engineer
Validation Engineer Exp with biological equipment validation exp min 5 yrs of pure validation Onsite
Senior Supplier Quality Engineer - Electronics (PCB, PCBA)
Supervisor, Manufacturing Test Engineering
Tijuana, Baja California, Mexico 21 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr