Process Microbiologist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Johnson and Johnson Innovative Medicine is recruiting for a Process Microbiologist! This position will be located in Malvern PA and support the Spring House PA site.

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at Johnson & Johnson we believe health is everything! Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity! Learn more at role supports a variety of GMP activities including large molecule drug substance cell banking operations and CAR-T manufacturing. You will serve as the site microbiology subject matter expert. You will act as a liaison with other internal quality organizations to standardize policies practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

Main responsibilities will include but are not limited to:

• Serve as the site microbiology subject matter expert for GMP manufacturing laboratory and facility operations providing technical guidance on microbiological controls contamination prevention and inspection readiness.
• Support environmental monitoring utility monitoring bioburden endotoxin microbial identification sterility assurance and related microbiological programs to ensure product quality and patient safety.
• Own and maintain site contamination control strategies. Lead monthly contamination control program reviews.
• Review trend and interpret microbiological data to identify adverse trends excursions and potential contamination risks; partner with cross-functional teams to define appropriate actions.
• Support investigations related to microbiological deviations environmental monitoring excursions contamination events aseptic processing observations and laboratory atypical results.
• Provide microbiology input for change controls risk assessments protocols validation activities cleaning and sanitization strategies and facility or process changes.
• Author review and approve microbiology-related procedures technical reports protocols specifications and controlled documents in accordance with cGMP expectations.
• Partner with Quality Manufacturing Engineering Technical Operations Validation and Laboratory teams to maintain robust microbial control strategies across the site.
• Support regulatory inspections internal audits and customer audits by preparing microbiology data explaining site programs and responding to microbiology-related observations.
• Provide training coaching and technical support to site personnel on microbiological control aseptic behaviors contamination prevention gowning cleaning and sampling practices.
• Drive continuous improvement initiatives to strengthen microbiology programs reduce contamination risk improve data integrity and enhance compliance.
• Maintain awareness of current industry guidance regulatory expectations and emerging microbiology technologies applicable to pharmaceutical and biologics manufacturing.
• Other duties may be assigned as necessary.

Qualifications

Education:

A minimum of a Bachelors Degree is required with a focus in Microbiology Biology Biochemistry Biotechnology or a related scientific field. An advanced degree in Microbiology or a related discipline is preferred.

Required:

• At least 6 years of relevant experience in microbiology quality control quality assurance manufacturing support or a related GMP-regulated pharmaceutical biotechnology biologics or medical device environment.
• Working knowledge of cGMP GLP data integrity and applicable regulatory expectations related to microbiological testing environmental monitoring aseptic processing and contamination control. Thorough understanding of Annex 1 requirements is required.
• Experience with environmental monitoring microbial identification bioburden endotoxin sterility assurance utilities monitoring cleanroom controls or microbiological method execution and oversight.
• Ability to evaluate microbiological data identify trends assess risk and make scientifically sound recommendations to support product quality and site compliance.
• Experience supporting or leading investigations for microbiological excursions contamination events deviations laboratory atypical results and corrective/preventive actions.
• Strong collaboration skills with the ability to work effectively across Quality Manufacturing Engineering Validation Technical Operations and Laboratory teams.
• Ability to manage multiple priorities work independently on routine assignments and escalate complex issues appropriately.
• A high degree of accuracy attention to detail scientific judgment and excellent interpersonal oral and written communication skills.

Preferred

• Experience supporting microbiology programs in biologics large molecule cell therapy vaccine sterile manufacturing or aseptic processing environments.
• Experience with Advanced Therapy Medicinal Products and regulations is preferred.
• Experience with contamination control strategy cleanroom qualification media fills disinfectant efficacy cleaning validation or microbiological method validation is preferred.
• Experience with regulatory inspections audit readiness and presenting microbiology programs or data to internal and external stakeholders is preferred.
• Demonstrated ability to influence without authority communicate complex microbiology topics clearly and drive cross-functional problem solving.

Other:

• This position is located primarily in Malvern PA but requires up to 20% domestic travel to the Johnson and Johnson Innovative Medicine site in Spring House PA to provide routine support to that site.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.
• Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Companys long-term incentive program.
• Employees are eligible for the following time off benefits:
• Vacation up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
• Holiday pay including Floating Holidays up to 13 days per calendar year
• Work Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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