Job Description
Senior Engineer, Computer Systems Validation
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 life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality 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 life-enhancing and life-saving treatments for patients annually.
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 start-ups utilizing novel technologies to produce state-of-the-art 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, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and laboratory documentation to support the commercial GMP manufacturing of biological drug substance and drug product. Responsibilities include coordinating multiple projects, documenting activities via protocols and summary reports. This role will help establish validation strategies and policies, as needed, including reviewing facilities changes and providing input on re-validation, assessing risks involved in processing steps related to equipment, facility/utility and computer systems validation. This role will help develop and/or review validation requirements and design deliverables.
This is a full-time, salaried role. This is onsite. The core hours are Monday – Friday 8:00AM – 5:00PM.
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
• Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.
• Author and Review of Validation Deliverables – Validation Master Plan (VMP), System Impact Assessment, Detailed Risk Assessment, User Requirement Specification Document, Functional Specification/Design Specification Document, Configuration Specification document, 21 CFR Part 11 Assessment, Application Qualification Protocol (IQ/OQ/PQ), Validation Summary Reports.
• Review and Provide guidance on Deviations/Defects during the IOQ/PQ executions.
• Leads all aspects of validation efforts relating to computer systems.
• Ensure site systems are compliant with the corporate Data Integrity program.
• Authored and Reviewed Data Integrity Assessments and Remediation plans.
• Identify data integrity risks and propose improvement plans. Participates in activities related to validation including design, maintenance, and change control.
• Support the Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11, GxP and applicable FDA/EMA Guidance.
• Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible for maintaining computer systems and software in a valid state.
• Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations.
• All other duties as assigned;
The Candidate
• Bachelor’s degree in a Science or Engineering field required with a minimum of five (5) years of direct CSV engineering experience;
• Able to work in a team setting and independently under minimum supervision;
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks;
• Experience with CSV Commissioning and Qualification activities in a regulated industry;
• In-depth knowledge of FDA guidelines and Global cGMPs relavant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
The Pay
The anticipated salary range for this position in Maryland is $85,000-120,000 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 multi-state 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, fast-paced 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 +00+ 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 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.
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 [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.
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 life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality 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 life-enhancing and life-saving treatments for patients annually.
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 start-ups utilizing novel technologies to produce state-of-the-art 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, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and laboratory documentation to support the commercial GMP manufacturing of biological drug substance and drug product. Responsibilities include coordinating multiple projects, documenting activities via protocols and summary reports. This role will help establish validation strategies and policies, as needed, including reviewing facilities changes and providing input on re-validation, assessing risks involved in processing steps related to equipment, facility/utility and computer systems validation. This role will help develop and/or review validation requirements and design deliverables.
This is a full-time, salaried role. This is onsite. The core hours are Monday – Friday 8:00AM – 5:00PM.
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
• Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.
• Author and Review of Validation Deliverables – Validation Master Plan (VMP), System Impact Assessment, Detailed Risk Assessment, User Requirement Specification Document, Functional Specification/Design Specification Document, Configuration Specification document, 21 CFR Part 11 Assessment, Application Qualification Protocol (IQ/OQ/PQ), Validation Summary Reports.
• Review and Provide guidance on Deviations/Defects during the IOQ/PQ executions.
• Leads all aspects of validation efforts relating to computer systems.
• Ensure site systems are compliant with the corporate Data Integrity program.
• Authored and Reviewed Data Integrity Assessments and Remediation plans.
• Identify data integrity risks and propose improvement plans. Participates in activities related to validation including design, maintenance, and change control.
• Support the Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11, GxP and applicable FDA/EMA Guidance.
• Collaborate with manufacturing, engineering, facilities, and quality assurance to Responsible for maintaining computer systems and software in a valid state.
• Participate in investigations and preventive/corrective actions for Validation including authoring and/or reviewing/approving Change Controls, CAPAs and Deviations.
• All other duties as assigned;
The Candidate
• Bachelor’s degree in a Science or Engineering field required with a minimum of five (5) years of direct CSV engineering experience;
• Able to work in a team setting and independently under minimum supervision;
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks;
• Experience with CSV Commissioning and Qualification activities in a regulated industry;
• In-depth knowledge of FDA guidelines and Global cGMPs relavant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP guidelines;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
The Pay
The anticipated salary range for this position in Maryland is $85,000-120,000 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 multi-state 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, fast-paced 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 +00+ 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 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.
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 [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.
💡 Quick Summary
Seeking a career-building opportunity? The Senior Computer Systems Validation Engineer position is now open for candidates interested in the IT Engineer & Developer Jobs sector. This role in Severn offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in IT Engineer & Developer Jobs is a plus.
