Biopharmaceutical SENIOR COMMISSIONING

2 weeks ago

Boulder, 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.

  • Senior Biopharmaceutical Commissioning Specialist

    3 weeks ago

    Boulder, Colorado, United States MMR Consulting Full time

    Job Summary:We are seeking a highly experienced Bioprocess Commissioning and Qualification Engineer to join our team at MMR Consulting. In this role, you will work on the commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry.Key Responsibilities:Provide technical guidance during...

  • Biopharmaceutical Commissioning Engineer

    4 weeks ago

    Boulder, Colorado, United States MMR Consulting Full time

    Job SummaryMRR Consulting is seeking a highly skilled Biopharmaceutical Commissioning Engineer to join our team. As a key member of our engineering team, you will be responsible for the commissioning and qualification of bioprocess systems and equipment in the biopharmaceutical industry.Key ResponsibilitiesProvide technical guidance on the commissioning and...

  • Biopharmaceutical - Manager, Commissioning & Qualification

    4 weeks ago

    boulder, 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 in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s Engineering expertise includes...

  • Biopharmaceutical - Manager, Commissioning & Qualification

    2 weeks ago

    Boulder, 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 in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s Engineering expertise includes...

  • Biopharmaceutical - Manager, Commissioning & Qualification

    2 weeks ago

    Boulder, CO, 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 in North America and globally. Its services include Engineering, Project Management, Validation and other Consulting services. MMR’s Engineering expertise includes...

  • Senior Marketing Director for Life Sciences

    4 weeks ago

    Boulder, Colorado, United States Mosaic Biosciences Full time

    Mosaic Biosciences is a pioneering discovery and preclinical development company that collaborates with leading biopharmaceutical companies to develop novel protein and antibody therapeutics.Our team of experienced researchers works closely with partners to design, manage, and execute research programs that accelerate the advancement of clinical candidates...

  • Senior Account Manager

    4 weeks ago

    Boulder, Colorado, United States Zayo Group Full time

    Job Title: Senior Account ManagerAbout the Role:Zayo Group is seeking a highly skilled Senior Account Manager to join our team. As a Senior Account Manager, you will be responsible for developing and maintaining relationships with our existing customers, as well as identifying and pursuing new business opportunities.Key Responsibilities:* Develop and execute...

  • Senior Business Development Manager

    4 weeks ago

    Boulder, Colorado, United States Ascend Analytics Full time

    Senior Business Development ManagerWe are seeking a highly skilled Senior Business Development Manager to join our team at Ascend Analytics. As a key member of our sales team, you will be responsible for driving sales and business development activities, interacting with Software Services and Consulting to promote the accomplishments and value-added unique...

  • Senior R&D Mechanical Engineer

    4 weeks ago

    Boulder, Colorado, United States Travertine Full time

    About TravertineTravertine is a Climate Tech company based in Boulder, CO that is rapidly scaling an electrochemical technology for carbon dioxide removal (CDR) and sustainable critical element extraction. Our process takes carbon dioxide from the air and sources of waste sulfate to produce carbonate minerals, sulfuric acid, and hydrogen. The sulfuric acid...

  • Senior Business Development Manager

    1 month ago

    Boulder, Colorado, United States Ascend Analytics Full time

    Job SummaryWe are seeking a highly skilled Senior Manager of Business Development to join our team at Ascend Analytics. As a key member of our sales and business development team, you will be responsible for driving sales and business development activities, interacting with Software Services and Consulting to promote the accomplishments and value-added...

  • Senior Engineering Manager

    4 weeks ago

    Boulder, Colorado, United States Goodwin Recruiting Full time

    Job OpportunityGoodwin Recruiting is seeking a seasoned engineering professional to fill the role of Associate Principal Engineer. This position offers a unique opportunity to drive strategic growth and lead high-impact projects.Key Responsibilities:Develop and implement Standard Operating Procedures (SOPs)Manage resources, timelines, budgets, and client...

  • Senior Security Engineer

    4 weeks ago

    Boulder, Colorado, United States Workday, Inc. Full time

    About the RoleAt Workday, Inc., we're revolutionizing the enterprise software market with a culture that puts our people first. As a member of our Security Analytics team, you'll collaborate with cross-functional teams to understand the threat landscape, participate in threat hunting exercises, and develop alerting logic using innovative techniques on large...

  • Beauty Service Provider

    4 weeks ago

    Boulder, Colorado, United States PS Lifestyle Full time

    PS Lifestyle Salon & Spa OpportunityWe are seeking a skilled and licensed Cosmetologist/ Hairstylist to join our team in one of our Senior Living Community Salons & Spas. As a Beauty Service Provider, you will have the opportunity to provide top-notch salon and spa services to our residents, while enjoying a rewarding and flexible work environment.Key...

  • Senior Sales Executive

    4 weeks ago

    Boulder, Colorado, United States Pager on Life Full time

    About the RolePager Health is a pioneering health platform company that empowers healthcare enterprises to deliver seamless, intelligent health experiences for their patients, members, and teams through integrated technology, AI, and concierge services. Our solutions help people access the right care at the right time in the right place, while reducing...

  • Mission Systems Engineer

    2 months ago

    Boulder, United States The Judge Group Full time

    Role Overview: We are looking for a dynamic and proactive engineer to support all phases of the program lifecycle, including concept development, design, requirements development, implementation, integration, launch, commissioning, operations, and maintenance. This role is ideal for an experienced systems engineer who can manage requirements, CONOPS, and...

  • Senior Product Manager, Content Platform

    4 weeks ago

    Boulder, Colorado, United States Workday Full time

    About the RoleAs a Product Manager for the Workday Content Platform, you will be responsible for empowering our customers with a set of immersive experience products that make Workday data more approachable and usable. You will work closely with designers, developers, researchers, and technical writers to create solutions that meet the needs of our...

  • Mission Systems Engineer

    1 month ago

    Boulder, United States The Judge Group Full time

    Role Overview: We are looking for a dynamic and proactive engineer to support all phases of the program lifecycle, including concept development, design, requirements development, implementation, integration, launch, commissioning, operations, and maintenance. This role is ideal for an experienced systems engineer who can manage requirements, CONOPS, and...

  • Funeral Director

    2 months ago

    Boulder, United States Service Corporation International Full time

    Job DescriptionJob DescriptionJOB RESPONSIBILITIES  Lead GenerationHolds self-accountable for prospecting a minimum of 1-2 hours each dayObtains referrals from families served by the locationNetworks and builds community and civic relationshipsExplains and presents presentations to families served and referred familiesMaintains and tracks activity levels to...

  • Patient Access Specialist

    4 weeks ago

    Boulder, United States Optum Full time

    Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data, and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion,...