Environment Technician

The Technician - Environmental Monitoring candidate provides Quality Control environmental monitoring support from start to finish for GMP Manufacturing of Cell Therapy products at our US Cell Therapy facility located in Princeton, NJ. This candidate performs analyses following specified instructions from supervisor, Standard Operating Procedures (SOPs), and analytical procedures. Reports testing results through standard laboratory paper-based documentation. Calculates results and compares to specification limits. Informs supervision immediately if lab results do not meet specifications. Expectation is to support at a minimum of 80% time on the production floor within a gown qualified / classified facility.

Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The role:

• Perform viable/non-viable environmental monitoring and read/review microbial samples
• Assist in the media-fill process validations and inspection of filled units
• Learn aseptic gowning and technique within a cleanroom environment
• Learn and apply GxP (GMP, GDP, GLP) to operations
• Perform document review of operation activities such as cleaning record, line clearance forms, and inventory/equipment checklist
• Document non-compliance and work with supervisor/lead if further investigation is needed
• Perform audits on aseptic technique and operation documentation
• Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
• Assist with equipment calibration program and maintenance record files
• Assist in the training of new employees and other technical personnel
• This candidate will be required to support operations that may occur seven days a week and/or at a day/swing shift.

The candidate:

• Bachelor of Science degree is required, Life Sciences discipline preferred
• 0 - 2 years' experience within the biologic, biopharmaceutical, or regulated industry
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Experience with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
• Knowledgeable and/or exposure to aseptic manufacturing processes including microbial and cell culture, and fill/finish.
• Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles)

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.