Associate Manufacturing Sciences Engineer

Company: Catalent Pharma Solutions, Inc.
Location: Bloomington
Posted on: August 8, 2022

Job Description:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Associate Manufacturing Sciences Engineer supports the scale up and transfer of processes into full-scale manufacturing based on data provide by Process Development or by the client.

This is a fulltime role working day shift 8:00AM - 8:30PM; 12 hour rotating schedule

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role

* Select appropriate equipment and single-use components to perform process at large scale, develop technical documentation (e.g., Process Flow Diagrams, Process Descriptions) to describe operation of the process at large scale
* Meet with Process Development or client technical team to understand bench and pilot-scale data, develop in-process test strategy for manufacturing process at large scale
* Write or direct the writing of GMP manufacturing documentation, including Process Batch Records, Buffer and Media Formulation records, Sample Plans, Bills of Materials
* Provide technical training as necessary to operators, provide on-the-floor oversight of the manufacturing process, as necessary
* Interact with client technical representatives, including Person in Plant observers on manufacturing floor
* Monitor process data, identify trends, present data, and propose action as necessary
* Perform technical troubleshooting and investigations of process issues, perform and document formal deviation investigations as needed
* Write or direct the writing of post run reports (e.g., Manufacturing Campaign Report)
* Provide technical guidance and oversight to the validation group to support Process Validation and Continued Process Verification
* Work with Process Development and Process Engineering to assess and implement new technology in large scale manufacturing
* Mentor junior-level Scientists and Engineers, co-ops, and interns
* Maintain relationship with process technology vendors to understand new technology development
* Other duties as assigned

The Candidate

* Bachelor of Science and 3-5 years of similar experience OR Master of Science 0-2 years
* Must be able to read and understand English-written job instructions and safety requirements
* Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Why You Should Join Catalent

* Competitive medical benefits and 401K
* 19 days 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 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.

Keywords: Catalent Pharma Solutions, Inc., Bloomington , Associate Manufacturing Sciences Engineer, Engineering , Bloomington, Indiana