Biopharmaceutical SENIOR COMMISSIONING

5 months ago

San Diego, United States MMR Consulting Full time

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.
  • Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
  • 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.
  • 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 for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
  • 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.
  • Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, 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 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.

  • Biopharmaceutical SENIOR COMMISSIONING

    4 months ago

    san diego, United States MMR Consulting Full time

    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....

  • Biopharmaceutical COMMISSIONING

    5 months ago

    San Diego, United States MMR Consulting Full time

    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....

  • Biopharmaceutical Recruitment Specialist

    1 week ago

    San Francisco, California, United States Talentvolt Recruitment Search & Solutions Full time

    Job Summary: We are seeking an experienced Senior Consultant/Principle/Director to join our team as a Biopharmaceutical Recruitment Specialist. The ideal candidate will have a minimum of 3 years' experience in full-cycle recruitment for the biopharmaceutical industry and a strong understanding of the industry's key players and...

  • Biopharmaceutical Process Expert

    1 week ago

    San Diego, California, United States TANVEX BIOPHARMA USA INC Full time

    About the RoleTANVEX BIOPHARMA USA INC is seeking a highly skilled Senior Engineer to lead our Manufacturing Science and Technology (MSAT) team. This is an exciting opportunity to join a dynamic organization and contribute to the development of biopharmaceutical processes.

  • Biopharmaceutical Process Engineer

    2 weeks ago

    San Diego, California, United States Tanvex BioPharma Inc Full time

    About the Role">The Senior Engineer, MSAT at Tanvex BioPharma Inc is responsible for leading and enabling MSAT development as the Subject Matter Expert (SME) for the company's existing and developing product portfolio. This individual will apply advanced engineering principles to transfer, monitor, validate, and troubleshoot drug substance manufacturing...

  • Senior IT Project Lead for Biopharmaceutical Projects

    2 weeks ago

    San Francisco, California, United States ShiftCode Analytics Full time

    Job Description:We are looking for a Senior IT Project Lead to oversee our biopharmaceutical project team at ShiftCode Analytics. As a senior member of our organization, you will be responsible for driving technical implementation, improving process efficiency, and ensuring timely delivery.About the Company:ShiftCode Analytics is a leading provider of...

  • Senior Biopharmaceutical Account Executive

    1 week ago

    San Francisco, California, United States Lifelancer Full time

    About the JobThe Sales and Business Growth Manager will play a critical role in driving business growth and expanding our presence in the biopharmaceutical/biotechnology CDMO industry. This individual will be responsible for developing and implementing sales and marketing strategies, identifying, creating, qualifying, strategizing, and closing on new...

  • Strategic Biopharmaceutical Consultant

    1 month ago

    San Francisco, California, United States Blue Matter Full time

    Company Overview">Blue Matter is a rapidly growing management consultancy with a strong global presence. We partner with clients in the biopharmaceutical industry to help them achieve commercial success across product lifecycles.Our expertise lies in new product planning, launch strategy, portfolio planning, and disease area strategy, particularly in...

  • Patent Attorney/Lawyer for Biopharmaceuticals

    2 weeks ago

    San Francisco, California, United States Genentech Full time

    Job SummaryGenentech is seeking a senior-level patent attorney/lawyer with 7+ years of experience in life sciences patent prosecution to join our team. As a key business partner and strategist, this individual will be responsible for creating and leveraging game-changing IP strategies that enable Genentech to do now what patients need next. This position...

  • Senior Business Analyst

    1 week ago

    San Francisco, California, United States Blue Matter Full time

    Are you passionate about the biopharmaceutical industry and have a knack for analyzing complex data? Do you want to work with a dynamic team to help clients achieve commercial success? Look no further!About Blue MatterBlue Matter is a rapidly growing management consultancy that partners with clients to drive business results across the lifecycle of their...

  • Senior Business Development Manager

    3 weeks ago

    San Diego, California, United States CK Group Full time

    At CK Group, we are seeking an accomplished Senior Business Development Manager to spearhead our biotechnology business in the San Diego area. This is a full-time, permanent position that offers a competitive salary range of $90,000-$100,000 plus commission.The ideal candidate will possess a PhD with direct experience in the industry and a proven track...

  • Senior Engineer for Pharmaceutical Manufacturing

    1 week ago

    San Diego, California, United States TANVEX BIOPHARMA USA INC Full time

    Job SummaryTANVEX BIOPHARMA USA INC is seeking a seasoned Senior Engineer to join our MSAT team. As a key member of our team, you will be responsible for applying advanced engineering principles to the transfer, monitoring, validation, and troubleshooting activities of drug substance manufacturing processes, partnering with cross-functional teams, driving...

  • Senior Data Architect

    7 days ago

    San Diego, California, United States Eli Lilly and Company Full time

    Leverage groundbreaking technology and expertise in data architecture to redefine solutions driving the advancement of medicine as a Lead Data Architect at Eli Lilly and Company.About the RoleThis is a senior-level position where you will combine data, cloud, and software engineering expertise to lead the delivery of data generation, computation, and...

  • Corporate Lawyer/ Senior Corporate Attorney

    3 weeks ago

    San Diego, California, United States Neurocrine Biosciences Full time

    Job Title: Corporate Lawyer/Senior Corporate AttorneyWe are seeking a highly skilled and experienced Corporate Lawyer to join our team at Neurocrine Biosciences. As a key member of our Legal Department, you will be responsible for providing top-notch legal counsel and support to our business teams.About UsNeurocrine Biosciences is a leading...

  • Senior Development Engineer

    2 weeks ago

    San Diego, California, United States Tanvex BioPharma Inc Full time

    Job Description Summary">The Senior Engineer, MSAT at Tanvex BioPharma Inc is responsible for leading and enabling MSAT development as the Subject Matter Expert (SME) for the company's existing and developing product portfolio. This individual will apply advanced engineering principles to transfer, monitor, validate, and troubleshoot drug substance...

  • Senior Bioprocessing Associate

    1 week ago

    San Diego, California, United States TANVEX BIOPHARMA USA INC Full time

    About TANVEX BIOPHARMA USA INCTanvex Biopharma USA Inc is a leading biopharmaceutical company dedicated to developing innovative therapies for patients worldwide. Our mission is to deliver high-quality products that improve patient outcomes while providing exceptional customer service. We are committed to fostering a collaborative and inclusive work...

  • Manufacturing Science and Technology Expert

    7 days ago

    San Diego, California, United States TANVEX BIOPHARMA USA INC Full time

    Lead Biopharmaceutical Manufacturing Process DevelopmentWe are seeking a highly experienced Senior Engineer to lead our biopharmaceutical manufacturing process development team at TANVEX BIOPHARMA USA INC. As a key member of our team, you will be responsible for developing and implementing new manufacturing processes, technologies, and equipment to improve...

  • Senior Controls Systems Specialist

    1 month ago

    San Diego, California, United States E Tech Group Full time

    Job OverviewE Tech Group is seeking a Senior Controls Engineer to lead or contribute to detailed hardware and software design of process automation control systems projects.This position involves defining architecture requirements, developing detailed software design specifications, programming PLC and SCADA applications, configuring thin client server...

  • Manufacturing Science and Technology Lead

    7 days ago

    San Diego, California, United States TANVEX BIOPHARMA USA INC Full time

    Job SummaryThe Senior Engineer will be responsible for leading all MSAT functions, including process transfer, monitoring, troubleshooting, and improvement. This individual must have advanced engineering principles and experience with biopharmaceutical manufacturing processes.We estimate the salary for this position to be around $120,000 - $160,000 per year,...

  • Leading Biopharmaceutical Process Engineer

    1 month ago

    San Diego, California, United States Halozyme Full time

    Company OverviewHalozyme, a pioneering biotechnology company, seeks a highly skilled Senior Engineer 2 to join its Manufacturing Science team. With a strong focus on innovation and collaboration, we empower our employees to make a meaningful impact in the lives of patients worldwide.