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Catalent Pharma Solutions Process Engineer I in Harmans, Maryland

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of 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. Interested in learning more about life at Catalent? Start here (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

The Process Engineer is responsible on aspects of introducing a new suite of biopharmaceutical products at our development and manufacturing sites. Most of the process will be liquid formulations manufactured under single-use production concept, in cleanroom environment.

The Process Engineer role is critical to our patients as this position is involved in onboarding new process equipment, working closely on the ground with production personnel and to prepare and execute commissioning and qualification protocols. This role will also organize the production process equipment layout, and coordinates with other departments on ensuring the validated status of process equipment.

Catalent Cell and 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:

  • Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for manufacturing equipment/systems and instrumentation.

  • Work independently on assigned projects and collaboratively in a multi-functional team environment supporting day-to-day manufacturing schedules and operations.

  • Hands-on work troubleshooting and repairing bioprocess equipment. Equipment includes fermentors, bioreactors, centrifuges, chromatography systems, incubators, BSCs, controlled temperature units, and laboratory equipment.

  • Work within Computerized Maintenance Management Systems (CMMS) to complete preventive and responsive maintenance work orders.

  • Work within manual and electronic Quality Systems to implement equipment, facility, and automation change control, document revisions, and conduct equipment/system/instrumentation failure investigations.

  • Work within manual and electronic Facilities Engineering documentation systems to maintain engineering drawings and equipment history files.

  • Lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors.

The Candidate

  • Bachelor of Science in Engineering, chemical or mechanical engineering preferred.

  • 2 - 5 years related work experience (GMP / Bio-Pharma maintenance/ engineering).

  • Demonstrated abilities in mechanical/electrical design, repairs and maintenance.

  • Understand and apply engineering principles to troubleshooting and repairing bioprocess equipment and instrumentation.

  • Knowledge of documentation practices associated cGMP operations (SOPs, batch records, calibration and maintenance records, equipment logbooks, change control, etc.).

  • Knowledge of biopharmaceutical equipment design, construction, operation, qualification, and maintenance.

  • Knowledge of equipment process controls and building automation systems.

  • Exhibit strong technical writing ability to clearly and effectively communicate technical ideas and concepts.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position 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

  • 19 days 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 www.catalent.com/careers to explore career opportunities.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking (https://catalent.wd1.myworkdayjobs.com/External) for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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