Senior Validation Engineering Specialist
4 weeks ago
Catalent Inc. is a global leader in the pharmaceutical industry, providing innovative solutions for the development and manufacturing of new treatments. As a Senior Validation Engineering Specialist, you will play a key role in ensuring the quality and integrity of our computer systems and equipment.
OverviewWe are seeking an experienced Senior Engineer to join our team at Catalent's Harmans, MD facility. The successful candidate will be responsible for coordinating validation projects related to manufacturing equipment, critical computer systems, and laboratory documentation. This is a full-time, salaried position with a competitive salary range of $85,000-$120,000 plus shift differential and annual bonus, when eligible.
Responsibilities- Author and review validation protocols for Computer Systems, including IQ, OQ, and PQ protocols related to manufacturing equipment.
- Develop and/or review validation requirements and design deliverables.
- Review and provide guidance on deviations/defects during IOQ/PQ executions.
- Lead all aspects of validation efforts relating to computer systems.
- 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.
- Experience with CSV Commissioning and Qualification activities in a regulated industry.
We offer a dynamic, fast-paced work environment, generous benefits, and opportunities for career growth. Our diverse, inclusive culture prioritizes continually improving processes to remain innovative. Join us in making a difference and advancing new medicines from early development to clinical trials and to the market.
-
Validation Specialist
1 week ago
Harmans, Maryland, United States Catalent Inc Full timeAbout Us:Catalent Inc. is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. We provide 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...
-
Computer System Validator
1 week ago
Harmans, Maryland, United States Catalent Inc Full timeAbout Catalent: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. We are dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development,...
-
Document Validation Professional
1 week ago
Harmans, Maryland, United States Vastek, Inc. Full timeJob DescriptionWe are looking for a skilled Document Validation Professional to join our team at Vastek, Inc. In this role, you will be responsible for reviewing and validating documents to ensure they meet regulatory requirements. Your attention to detail and analytical skills will be essential in identifying and resolving discrepancies.Key...
-
Senior Specialist Batch Administration
1 week ago
Harmans, Maryland, United States Catalent Inc Full timeOverviewCatalent Inc, a global leader in the development and manufacturing of pharmaceuticals, is seeking a Senior Specialist for its Batch Disposition team. Located on the Harmans/BWI campus, our state-of-the-art facility offers an exciting opportunity to work with cutting-edge technology and a talented team of professionals.
-
Senior Quality Assurance Specialist
1 week ago
Harmans, Maryland, United States Catalent Inc Full timeCatalent Inc. is a leading contract development and manufacturing organization (CDMO) dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers.As a Senior Quality Assurance Specialist at Catalent Inc., you will be responsible for providing quality assurance support for GMP manufacturing of master/working cell banks,...
-
Senior Electrical Construction Manager
3 days ago
Harmans, Maryland, United States Lighting Maintenance Inc Full timeElectrical Project Management OpportunityThis is an excellent opportunity for a Senior Electrical Construction Manager to join our team at Lighting Maintenance Inc. As an Electrical Project Supervisor, you will be responsible for overseeing electrical and construction crews, ensuring successful project completion while adhering to timelines, budgets, and...
-
Batch Release Specialist
1 week ago
Harmans, Maryland, United States Catalent Inc Full timeAbout Catalent IncCatalent is a global company that partners with the pharmaceutical industry to develop and manufacture new treatments for patients worldwide.Our mission is to help people live better, healthier lives. We have a state-of-the-art CGMP manufacturing facility located on the Harmans/BWI campus, which is close to Washington, DC's I-270 Technology...
-
Senior Electrical Installation Specialist
2 weeks ago
Harmans, Maryland, United States Shrader Electric Co Full timeJob SummaryWe are seeking an experienced Electrician Foreman to join our team at Shrader Electric Co.The successful candidate will have a proven track record of leading electrical installation teams, with a strong focus on quality, safety, and customer satisfaction.Key responsibilities include:Leading the installation of electrical systems, including F/A,...
-
Capital Construction Procurement Specialist
4 weeks ago
Harmans, Maryland, United States LanceSoft, Inc. Full timeJob Title: Capital Construction Procurement SpecialistWe are seeking an experienced Capital Construction Procurement Specialist to join our team at LanceSoft, Inc.This role will be based in the United States, with opportunities for remote work and occasional travel to Conshohocken, PA.About the Role:The successful candidate will be responsible for managing...
-
Quality Assurance Specialist
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeCatalent Inc. is a global leader in the development and manufacturing of pharmaceutical products. We are currently seeking a highly skilled Quality Assurance Specialist to join our team.About the Role:The successful candidate will be responsible for providing quality assurance support for GMP manufacturing of master/working cell banks, biological bulk drug...
-
Batch Records Specialist
4 days ago
Harmans, Maryland, United States Vastek, Inc. Full timeJob Title: Batch Records ReviewerWe are seeking a candidate with genuine experience working with Batch Records in the Pharma Industry. The ideal candidate will have strong documentation skills and be able to review records efficiently.Key Responsibilities:Reviewing batch records to ensure accuracy and completenessVerifying documentations against established...
-
Harmans, Maryland, United States Vastek, Inc. Full timeAbout Vastek Inc.Vastek Inc is a certified minority-owned small business company specializing in Engineering, Validation, Regulatory, IT, and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.Our team of dedicated professionals has rich experience in Healthcare, IT consulting, and staffing, with a strong...
-
Pharmaceutical Equipment Specialist
1 week ago
Harmans, Maryland, United States Catalent Inc Full timeThe Ideal CandidateWe are looking for a seasoned engineer with 10+ years of experience in GMP/bio-pharma maintenance or engineering, holding a Bachelor of Science in Engineering (Chemical or mechanical preferred). The ideal candidate should possess hands-on expertise in repairing bioprocess equipment, including fermenters, bioreactors, centrifuges,...
-
Pharmaceutical Production Specialist
3 days ago
Harmans, Maryland, United States Catalent Inc Full timeCatalent Inc is a global leader in contract development and manufacturing organizations (CDMOs). We are looking for a skilled Engineer II, MS&T to support our manufacturing operations in Maryland.The role involves working as a subject matter expert (SME) for biologic Upstream/Downstream Processes and providing technical support to ensure smooth production....
-
Experienced Fleet Maintenance Technician
4 weeks ago
Harmans, Maryland, United States Lighting Maintenance Inc Full timeWe are seeking a skilled Fleet Maintenance Technician to join our team at Lighting Maintenance Inc. in the United States.Salary: $75,000 - $80,000 per year, plus a potential sign-on bonus of up to $2,500.The successful candidate will be responsible for maintaining and repairing a diverse fleet of heavy-duty vehicles and equipment, including bucket trucks,...
-
Harmans, Maryland, United States Catalent Inc Full timeCatalent Inc, a global leader in the development and manufacturing of new treatments for patients worldwide, is seeking an experienced Laboratory Information Management System (LIMS) Administrator to join their team. This role will be responsible for administering accounts, roles, and system functions per global/local LIMS procedures.The ideal candidate will...
-
Directional Drilling Crew Lead Specialist
2 weeks ago
Harmans, Maryland, United States Lighting Maintenance Inc Full timeThe ideal candidate will have a CDL A Driver's license, high school diploma or equivalent, and previous experience as a Foreman or in a similar supervisory role in the construction industry. They will possess strong knowledge of drilling techniques, equipment, and safety practices, proficiency in utility locating methods and equipment, and excellent...
-
Directional Drilling Crew Lead
6 days ago
Harmans, Maryland, United States Lighting Maintenance Inc Full timeCompensation and BenefitsThe salary for this position is estimated to be around $80,000 - $110,000 per year, depending on experience. In addition to a competitive salary, we offer a range of benefits, including health insurance, retirement plans, and paid time off.Key ResponsibilitiesDrilling Operations:Plan, organize, and coordinate drilling activities...
-
Capital Construction Procurement Specialist
1 month ago
Harmans, United States LanceSoft, Inc. Full timeTitle: Capital Construction Procurement Specialist/ Coordinator 3 - ProcurementDuration: 24 MonthsLocation: Will be remote until the site opens in Wilson, NC. After the site opens, role will be onsite.Travel; Travel will be required to Conshohocken, PA. Travel can be 1 week per month until Wilson, NC site opens and is receiving workers. Leader stated travel...
-
harmans, United States LanceSoft, Inc. Full timeTitle: Capital Construction Procurement Specialist/ Coordinator 3 - ProcurementDuration: 24 MonthsLocation: Will be remote until the site opens in Wilson, NC. After the site opens, role will be onsite.Travel; Travel will be required to Conshohocken, PA. Travel can be 1 week per month until Wilson, NC site opens and is receiving workers. Leader stated travel...
-
harmans, United States LanceSoft, Inc. Full timeTitle: Capital Construction Procurement Specialist/ Coordinator 3 - ProcurementDuration: 24 MonthsLocation: Will be remote until the site opens in Wilson, NC. After the site opens, role will be onsite.Travel; Travel will be required to Conshohocken, PA. Travel can be 1 week per month until Wilson, NC site opens and is receiving workers. Leader stated travel...
-
Technical Writer
4 weeks ago
Harmans, United States Alltech Consulting Services Inc Full timeJob Description:Increase your chances of an interview by reading the following overview of this role before making an application.The Manufacturing Technical Specialist will provide support for Manufacturing Management and Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Manufacturing Technical Specialist will...
-
Manufacturing Associate
2 weeks ago
Harmans, United States Planet Pharma Full timeManufacturing Support Needed- Noon-Midnight ShiftThe Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell...
-
Planet Pharma | Manufacturing Associate
2 weeks ago
harmans, United States Planet Pharma Full timeTemp to hire, initial 3 month contractHarmans, MDShift: 12pm - 12am (2-2-3 rotation) The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk...
-
Manufacturing Associate
1 day ago
Harmans, United States Planet Pharma Full timeTemp to hire, initial 3 month contractHarmans, MDShift: 12pm - 12am (2-2-3 rotation) The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk...
-
Manufacturing Associate
2 weeks ago
Harmans, United States Planet Pharma Full timeTemp to hire, initial 3 month contractHarmans, MDShift: 12pm - 12am (2-2-3 rotation) The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk...
-
Manufacturing Associate
2 weeks ago
Harmans, United States LanceSoft, Inc. Full timeJob Tittle: Manufacturing Associate Location: Harmans MD 21077 Duration: 3 months (Temp To Hire)Shift timing: 12pm – 12am (2-2-3 rotation)Job Description:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to...
-
Manufacturing Associate
2 weeks ago
Harmans, United States Infojini Inc Full timeJob Title – Manufacturing AssociateLocation – Harmans MD 21077Duration – 3+ months contract to hire positionShift Hours – 12pm – 12am (2-2-3 rotation)Job Summary:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and...
-
Infojini Inc | Manufacturing Associate
2 weeks ago
harmans, United States Infojini Inc Full timeJob Title – Manufacturing AssociateLocation – Harmans MD 21077Duration – 3+ months contract to hire positionShift Hours – 12pm – 12am (2-2-3 rotation)Job Summary:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and...
-
LanceSoft, Inc. | Manufacturing Associate
2 weeks ago
harmans, United States LanceSoft, Inc. Full timeJob Tittle: Manufacturing Associate Location: Harmans MD 21077 Duration: 3 months (Temp To Hire)Shift timing: 12pm – 12am (2-2-3 rotation)Job Description:The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to...
-
Manufacturing Associate
3 weeks ago
Harmans, United States Adecco Full timeJob DescriptionJob DescriptionAddecco is currently seeking a Manufacturing AssociatePay: $34.00/hrAssignment Type: Temp-to-Hire Shift: 12 PM – 12 AM Are you ready to advance your career in GMP manufacturing? Join our team as a Manufacturing Associate and play a vital role in upstream or downstream biologics production for Phase I/II and commercial GMP...
-
Truck Driver CDL Class A Regional Specialist
3 weeks ago
Harmans, United States Ryder System Full timeRyder System is seeking a highly skilled Truck Driver CDL Class A Regional to join our team. As a vital member of our logistics operations, you will be responsible for delivering goods safely and efficiently across various locations.Compensation PackageThe estimated salary for this position ranges from $1,900 to over $2,300 per week, depending on your...
-
Manufacturing Associate
3 weeks ago
Harmans, United States BCForward Full timeJob DescriptionJob DescriptionBCforward is currently seeking a highly motivated Manufacturing Associate for an opportunity in Severn, MDPosition Title: Manufacturing AssociateLocation: Severn, MD 21077Expected Duration: Temp to HireShift: 12PM to 12 AM (2-2-3 rotation)Pay: $34/hr Job DescriptionManufacturing Associate II is responsible for supporting the...