Lead Operator

Lead Operator

Position Summary

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.

The Lead Operator micronizemills client provided material including both active pharmaceutical ingredients and excipients as per Catalent Micron Technologies procedures and policies client instructions and cGMP guidelines. The Lead Operator models Catalent values and leadership behaviors in all interactions.

This position is 100% on-site at the Malvern site.

Shift: Monday - Friday 6 am - 2:30 pm

The Role

• Set up operate equipment and monitor production processes

• Report production on batch records in accordance with good documentation procedures (GDPs)

• Ability to work in a regulated environment with adherence to standard operating procedures

• Adhere to cGMP standards

• Identify communicate and assist in writing non-routine events deviations and GMP deficiencies.

• Produce thorough clear and consistent documentation in compliance with Quality

• Standards (Attributable Legible Contemporaneous Original and Accurate).

• Demonstrate willingness to accept change learn and work with new processes.

• All other duties as assigned.

The Candidate

• High School Diploma or GED.

• Minimum 3 years micronization/milling experience and work in a regulated environment preferred.

• Ability to work weekday and weekend OT.

• Employees be able to lift or move items up to 44 lbs. (20kg) individually or with a two-person lift between 45 lbs and 76 lbs. (35kg). 77 lbs and over with a lift assistance device.

• Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) as well as novel compounds of unknown potency and toxicity.

• Perform moderate physical labor including: lifting climbing bending crouching reaching and twisting. Stand or walk for up to 8 hours per day. Climb steps/ladders and occasionally work from elevated platforms. Wear a respirator hood and pass the required respiratory medical exam. Work in loud environments and wear various types of hearing protection. Ability to work with chemicals health/physical hazardous material safely and in compliance with the site safety program.

Why You Should Join Catalent

• Competitive medical benefits and 401K

• 152 hours of PTO 8 Paid Holidays

• Dynamic fast-paced work environment

• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.