The Automation Engineer (GMP Operations) will be part of a team reporting to the Manager Automation and will provide key support for various manufacturing systems. This will include Programmable Logic controllers (PLC), OSI-PI for Data Historian, IGNITION for data reporting & remote alarms, process equipment such as Single-Use (SU) Bioreactors, SU Chromatography, Purification & Filtration systems, and Other Original Equipment Manufacturer (OEM) systems in Manufacturing suites and QC labs. Under the direction of the senior engineers, this role will be responsible for trouble-shooting challenging equipment / automation issues to improve manufacturing performance (e.g. yield improvements, etc.) and maintaining the automation systems in compliance with cGMPs.

　　Initial responsibilities include establishing the appropriate controls and administrating the automated and computerized systems at the Harmans, MD site. For various project assignments/initiatives, the automation engineer is responsible for partnering with Quality Assurance, Computer System Validation, and Manufacturing groups in maintaining compliance with CGMP requirements. The role provides multiple opportunities to learn new skills in IT, automation and process analytical technologies and help advance innovative gene therapies to patients.

　　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

　　Support of a large-scale capital project to develop and implement automation systems in a new manufacturing area, then continued support of those systems as described throughout the description

　　Understand and support all GMPs, safety, and environmental regulations. Periodically reviews automation documents, preventive and corrective maintenance, and SOPs to ensure compliance with GMP and safety.

　　On atypical automation situations, develops and supports corrective actions.

　　Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Supports installing and placing new equipment into operations.

　　Ensures compliance to FDA regulations and follows GAMP in task execution, including change control and deviation investiations. Participates in audits and training programs for automated systems

　　On-floor support of manufacturing, process development and laboratory activities.

　　Maintain technical documentation (manuals, drawings, software, etc.).

　　Provides client services support for business area applications.

　　The Candidate

　　Bachelor’s or Associates degree in Engineering, Information Technology, Science, or related field.

　　Effective interpersonal and communication skills (written and oral) are required.

　　2 to 5 years’ experience in an Automation role supporting process, laboratory or facility equipment.

　　A working knowledge of the regulatory requirements for pharmaceutical operations.

　　A combination of education, certification, and experience may be substituted for the above, as appropriate

　　Catalent Benefits

　　Potential for career growth within an expanding team

　　Defined career path and annual performance review & feedback process

　　Cross functional exposure to other areas of within the organization

　　Medical, Dental, Vision, and 401K are all offered from day one of employment

　　152 hours of paid time off annually + 8 paid holidays

　　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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

　　California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .