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Process Microbiologist-4948131206
Description
Janssen Biotech, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Process Microbiologist located in Malvern, PA.
For more than 30 years, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. pursues innovative solutions in the therapeutic areas of immunology, oncology, urology and nephrology. With the same unwavering passion for new challenges, we dedicate ourselves to delivering solutions for these disease states where unmet needs continue to exist. Rooted in rich scientific collaborations and community-based relationships, we have access to some of the top minds in science today, allowing us to advance the treatment of patients through our innovative medicines. Our discoveries lead us not only to new treatments, but also to new ways to empower patients and expand their access to quality care. For more about Janssen Biotech, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenbiotech.com
The Process Microbiologist reports to the Manager, QC Microbiology. Responsible for the development and/or improvement and maintenance of the contamination prevention programs and microbiological hygiene programs. Acts as the primary microbiological SME and works with Investigators on microbiological contamination issues in the facility. The Process Microbiologist supports the control and implementation of the training curriculum concerning microbiological hygiene & contamination prevention. He/she gives pragmatic advice to production operators, team leaders and management on topics concerning contamination risk prevention. The Process Microbiologist must have a detailed understanding of the production processes and critical process steps in relation to contamination control. He/she will provide meaningful input on the aseptic techniques involved in these process steps and other areas related to contamination control such as equipment/facility design, cleaning & disinfection, gowning and transport of man & materials into and throughout the facility. He/she must build a strong network both inside and outside the Quality Control Microbiology Department. The Process Microbiologist is present on the shop floor where he/she will work closely together with the operators and management of the Manufacturing, and Maintenance departments. Also the Process Microbiologist will work closely together with other departments such as the QC Microbiology Laboratory and QA & Compliance.
The Process Microbiologist will establish, document and escalate risks related to contamination of production processes and products. Identify preventative actions related to contamination control that are a result of risk analyses, observations and deviations and ensure implementation by follow up & control. Promptly advises supervisor/manager of issues, incidents or abnormalities and recommends appropriate steps for resolution. Drives improvements related to the reduction of contamination risks and the improvement of microbiological hygiene, and ensures that these improvements are realized and implemented. Has a detailed understanding of the production processes and critical process steps in relation to contamination control. Provides meaningful input on the aseptic techniques involved in these process steps and other areas related to contamination control such as equipment/facility design, cleaning & disinfection, gowning and transport of man & materials into and through the facility. Responsible for creating/improving training and training curricula related to microbiological hygiene and contamination prevention as needed. Organize and give training on these subjects where required. Perform risk analyses for projects & business innovation initiatives from a microbiological perspective. Perform and analyze trending of environmental monitoring, water system and utility data. Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives to for improvement in close cooperation with area owners, operators and management. Provide effective and timely communication to all levels in the organization as appropriate. Achieve goals through actively working with departments and individuals involved and being customer -focused while maintaining a focus on the business requirements. Network and communicate with other Process Microbiologists at the other LM sites and across the organization.
The Process Microbiologist may write new or revise existing Standard Operating Procedures (SOPs) and/or Work Instructions (WIs). Participates in and/or leads special projects or studies. Supports short and long term projects, meeting established deadlines. Represents department in meetings and on teams, as requested. Provides training, as requested. May assist in internal/external audits. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures. Successfully completes regulatory and job training requirements. Makes a positive contribution as demonstrated by: making suggestions for improvement; providing overtime as needed; learning new skills, procedures and processes. Maintains current knowledge of regulations and industry trends. Requires thorough knowledge of applicable cGMP requirements. Requires excellent communication skills, both written and verbal English. Requires ability to make well balanced decisions, awareness of risks and consequences.
Qualifications
A minimum of a Bachelor’s Degree in Biology, Biochemistry, Microbiology or related discipline, with 8+ years related experience in biopharmaceutical or pharmaceutical industry, OR A Master’s Degree in above disciplines, with 5+ years related experience, OR A PhD in above disciplines, with 3+ years related experience is required. Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment strongly preferred. Must be able to effectively don and wear required gowning materials (one-piece jumpsuits, head covers, gloves, surgical masks and the like). Must be able to communicate effectively, clearly and accurately in verbal and written English. Must be able to read and interpret documents such as SOPs, operating and maintenance instructions and procedure manual. Must be able to read, analyze and interpret general business periodicals, professional journals, technical procedures, governmental regulations, common scientific and technical journals and legal documents, as appropriate. Must be able to write accurate, grammatically correct reports, business correspondence and procedure manuals in English. Must be able to clearly and effectively present information and respond to questions from groups of managers and employees.
Must be able to utilize software and customized programs to meet business needs. Must possess solid knowledge of routine and non-routine environmental testing and sampling methods, techniques and related equipment. Thorough knowledge of cGMP’s and applicable industry regulations is required. While performing the duties of this job, the employee: Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position; Is occasionally required to travel, domestically and/or internationally; Is frequently required to talk or hear; Is occasionally required to lift up to 20 pounds. Janssen Biotech is committed to working with any applicant or employee to make reasonable accommodations in job structure in consideration of any known physical challenges or disabilities.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI NA
Primary Location:North America-United States-Pennsylvania-Malvern
Organization: Janssen Biotech, Inc. (6014)
Job Function: Quality Control
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Process Microbiologist-4948131206
Description
Janssen Biotech, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Process Microbiologist located in Malvern, PA.
For more than 30 years, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. pursues innovative solutions in the therapeutic areas of immunology, oncology, urology and nephrology. With the same unwavering passion for new challenges, we dedicate ourselves to delivering solutions for these disease states where unmet needs continue to exist. Rooted in rich scientific collaborations and community-based relationships, we have access to some of the top minds in science today, allowing us to advance the treatment of patients through our innovative medicines. Our discoveries lead us not only to new treatments, but also to new ways to empower patients and expand their access to quality care. For more about Janssen Biotech, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenbiotech.com
The Process Microbiologist reports to the Manager, QC Microbiology. Responsible for the development and/or improvement and maintenance of the contamination prevention programs and microbiological hygiene programs. Acts as the primary microbiological SME and works with Investigators on microbiological contamination issues in the facility. The Process Microbiologist supports the control and implementation of the training curriculum concerning microbiological hygiene & contamination prevention. He/she gives pragmatic advice to production operators, team leaders and management on topics concerning contamination risk prevention. The Process Microbiologist must have a detailed understanding of the production processes and critical process steps in relation to contamination control. He/she will provide meaningful input on the aseptic techniques involved in these process steps and other areas related to contamination control such as equipment/facility design, cleaning & disinfection, gowning and transport of man & materials into and throughout the facility. He/she must build a strong network both inside and outside the Quality Control Microbiology Department. The Process Microbiologist is present on the shop floor where he/she will work closely together with the operators and management of the Manufacturing, and Maintenance departments. Also the Process Microbiologist will work closely together with other departments such as the QC Microbiology Laboratory and QA & Compliance.
The Process Microbiologist will establish, document and escalate risks related to contamination of production processes and products. Identify preventative actions related to contamination control that are a result of risk analyses, observations and deviations and ensure implementation by follow up & control. Promptly advises supervisor/manager of issues, incidents or abnormalities and recommends appropriate steps for resolution. Drives improvements related to the reduction of contamination risks and the improvement of microbiological hygiene, and ensures that these improvements are realized and implemented. Has a detailed understanding of the production processes and critical process steps in relation to contamination control. Provides meaningful input on the aseptic techniques involved in these process steps and other areas related to contamination control such as equipment/facility design, cleaning & disinfection, gowning and transport of man & materials into and through the facility. Responsible for creating/improving training and training curricula related to microbiological hygiene and contamination prevention as needed. Organize and give training on these subjects where required. Perform risk analyses for projects & business innovation initiatives from a microbiological perspective. Perform and analyze trending of environmental monitoring, water system and utility data. Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives to for improvement in close cooperation with area owners, operators and management. Provide effective and timely communication to all levels in the organization as appropriate. Achieve goals through actively working with departments and individuals involved and being customer -focused while maintaining a focus on the business requirements. Network and communicate with other Process Microbiologists at the other LM sites and across the organization.
The Process Microbiologist may write new or revise existing Standard Operating Procedures (SOPs) and/or Work Instructions (WIs). Participates in and/or leads special projects or studies. Supports short and long term projects, meeting established deadlines. Represents department in meetings and on teams, as requested. Provides training, as requested. May assist in internal/external audits. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures. Successfully completes regulatory and job training requirements. Makes a positive contribution as demonstrated by: making suggestions for improvement; providing overtime as needed; learning new skills, procedures and processes. Maintains current knowledge of regulations and industry trends. Requires thorough knowledge of applicable cGMP requirements. Requires excellent communication skills, both written and verbal English. Requires ability to make well balanced decisions, awareness of risks and consequences.
Qualifications
A minimum of a Bachelor’s Degree in Biology, Biochemistry, Microbiology or related discipline, with 8+ years related experience in biopharmaceutical or pharmaceutical industry, OR A Master’s Degree in above disciplines, with 5+ years related experience, OR A PhD in above disciplines, with 3+ years related experience is required. Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment strongly preferred. Must be able to effectively don and wear required gowning materials (one-piece jumpsuits, head covers, gloves, surgical masks and the like). Must be able to communicate effectively, clearly and accurately in verbal and written English. Must be able to read and interpret documents such as SOPs, operating and maintenance instructions and procedure manual. Must be able to read, analyze and interpret general business periodicals, professional journals, technical procedures, governmental regulations, common scientific and technical journals and legal documents, as appropriate. Must be able to write accurate, grammatically correct reports, business correspondence and procedure manuals in English. Must be able to clearly and effectively present information and respond to questions from groups of managers and employees.
Must be able to utilize software and customized programs to meet business needs. Must possess solid knowledge of routine and non-routine environmental testing and sampling methods, techniques and related equipment. Thorough knowledge of cGMP’s and applicable industry regulations is required. While performing the duties of this job, the employee: Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position; Is occasionally required to travel, domestically and/or internationally; Is frequently required to talk or hear; Is occasionally required to lift up to 20 pounds. Janssen Biotech is committed to working with any applicant or employee to make reasonable accommodations in job structure in consideration of any known physical challenges or disabilities.
BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI NA
Primary Location:North America-United States-Pennsylvania-Malvern
Organization: Janssen Biotech, Inc. (6014)
Job Function: Quality Control
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.