CQV Engineer

CQV Engineer

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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.

Our FDAlicensed stateoftheart CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington DCs I270 Technology Corridor top universities and government agencies. The Harmans/BWI1 EMA and FDA approved facility at approximately 200000 sq. ft. houses 10 CGMP manufacturing suites fill/finish central services testing labs and a warehouse. The Harmans/BWI2 facility at approximately 145000 sq. ft. is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vectorbased therapies and vaccines.

Catalent Pharma Solutions in Harmans MD is hiring an Engineer CQV (Commission Qualification & Validation) 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 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.

This is a fulltime salaried role. The core hours are Monday Friday from 8:00AM 4:30PM.

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:

• Will be a company SME on bioprocess equipment across all operating departments (process development manufacturing testing/Quality Control);
• Work closely with facilities mechanics to minimize equipment down times expedite preventive maintenance (PM) schedules;
• Work closely with manufacturing and laboratory personnel to troubleshoot and repair equipment instrumentation and controls issues;
• Work with subcontractors as needed on equipment preventive maintenance and repairs;
• Assist in maintaining PM programs for the bioprocess equipment and instrumentation. This includes generating PM SOPs/records establishing PM frequencies specifying spare parts and recommending/maintaining inventory levels;
• Work with equipment vendors and Catalents purchasing department to quote/purchase/procure equipment parts and instrumentation;
• Initiate/complete various types of GMP documentation such as change control deviations corrective and preventive actions (CAPAs) documentation revision;
• Operate Building Automation System (BAS) HMI SCADA Historian and equipment monitoring/alarm reporting systems for the facility;
• Accurately maintain/complete all equipment logbooks and maintenance records within the CMMS;
• Assist in training of mechanics and manufacturing personnel on the various pieces of bioprocess equipment throughout the facility.
• Assist with writing reviewing and executing validation protocols.
• All other duties as assigned

The Candidate:

• Bachelor of Science in Engineering (Chemical or Mechanical engineering preferred.;
• Two 2 years related work experience (GMP / BioPharma maintenance/ engineering) required;
• Demonstrated abilities in mechanical/electrical design repairs and maintenance;
• Understand and apply engineering principles to troubleshooting and repairing bioprocess equipment and instrumentation;
• Demonstrate use of problem solving and continuous improvement techniques;
• 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 040 pounds;

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.