Senior Process Engineer - Equipment
Senior Process Engineer - Equipment
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$ 93280 - 128260
1 Vacancy
Job Description
Senior Equipment Process Engineer
Position Summary:
Catalent is a global highgrowth 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.
Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative startups utilizing novel technologies to produce stateoftheart vaccines and therapies for people when they are most in need. As a Catalent employee you will actively contribute to the delivery of our services and products to our customers and their patients.
Catalent Pharma Solutions in Harmans MD is hiring a Senior Engineer Equipment who is responsible for aspects of introducing a new suite of biopharmaceutical products at our development and manufacturing sites. The majority of process will be liquid formulations manufactured under singleuse production concept in a cleanroom environment. This role is involved in onboarding new process equipment working closely on the ground with production and development personnel preparing and executing commissioning and qualification protocols organizing the production process equipment layout and coordinating with other departments to ensure the validated status of process equipment. The project will require a fulltime engineer and is a tremendous opportunity for an ambitious handson engineer to become a core team player in a team working for an expanding CDMO. All work to be carried out in compliance with cGMP and company standard operating procedures and policies.
This is a fulltime salaried role. This is onsite. The core hours are 8:00AM 5:00PM
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 Role
- Analyze and develop engineering solutions to maintenance continuous improvement quality and safety initiatives and failure investigations for manufacturing equipment/systems instrumentation and filling equipment;
- Work independently on assigned projects and collaboratively in a multifunctional team environment supporting daytoday manufacturing schedules and operations;
- Handson work troubleshooting and repairing bioprocess equipment. Equipment includes fermenters bioreactors centrifuges chromatography systems incubators BSCs controlled temperature units fillers isolators and laboratory equipment;
- Handson work with Fill/finish process scaleup and technology transfer including the use of gap analysis root cause analysis and risk assessment tools (e.g. Fish bone diagrams FMEA etc.;
- Work within Computerized Maintenance Management Systems (CMMS) to complete This position requires a professional who will be expected to perform tasks autonomously at times; minimum supervision required on daytoday activities and accomplished tasks;
- Will be required at times to lead engineering projects from start to finish including documentation scheduling overseeing maintenance mechanics and/or contractors;
- Supervisory input focused on status and future of project or technical area and longterm development path;
- 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;
- All other duties as assigned;
The Candidate
- Bachelor of Science in Engineering chemical or mechanical engineering required with 4 years related work experience (GMP / BioPharma maintenance/ engineering).
- Demonstrated abilities in mechanical/electrical design repairs and maintenance;
- Understand and apply engineering principles to troubleshooting and repairing bioprocess equipment and instrumentation;
- Experience with filling of drug product and familiarity with aseptic filling equipment including isolator technology;
- Familiarity with cGMPs regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing;
- Application of current Good Manufacturing Practices (cGMPs) to Phase I/II bulk and finished biologics;
- 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;
- Individual may be required to sit stand walk regularly and occasionally lift 015 pounds;
The Pay
- The anticipated salary range for this position in Maryland is $plus shift differential and annual bonus when eligible. The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job type and length of experience within the industry skillset education business needs etc. Catalent is a multistate employer and this salary range may not reflect positions that work in other states.
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 Hours 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic fastpaced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- Medical dental and vision benefits effective day one of employment
- Tuition Reimbursement Let us help you finish your degree or start a new degree!
- WellHub program to promote overall physical wellness
- Perkspot offers exclusive or private discounts from approximately 900 merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 lifesaving and lifeenhancing 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.
Required Experience:
Senior IC
Employment Type
Full-Time
