Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:Professional
All Job Posting Locations:Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America
Job Description: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.
This 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.
QualificationsEducation:
A minimum of a Bachelor's 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 Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's 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
Required Skills: Preferred Skills: 
