Current jobs related to Process Validation Specialist - Pittsburgh, Pennsylvania - Krystal Biotech

  • Validation Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States BGS US Full time

    Job Opportunity at BGS USBGS US, a leading provider of beta rays for radiation sterilization, is seeking a skilled Validation Engineer to join our team at our new production facility in Imperial, PA.We are looking for a highly motivated and safety-oriented individual to play a vital role in the startup of our high-volume production operations. As a...

  • Validation Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States BGS US Full time

    Job Title: Validation EngineerWe are seeking a highly skilled and detail-oriented Validation Engineer to join our team at BGS US. As a key member of our operations team, you will play a vital role in ensuring the quality and safety of our products.Key Responsibilities:Quality Assurance: Conduct quality inspections, audits, and root cause analysis to ensure...

  • Data Validation Analyst

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Gecko Robotics Inc Full time

    About the RoleAs a Data Validation Specialist at Gecko Robotics Inc, you will play a crucial role in ensuring the accuracy and reliability of our customers' inspection data. You will work closely with our internal teams to develop and implement data validation processes, ensuring that every customer deliverable meets the highest standards of quality.Key...

  • Specimen Processing Specialist

    1 week ago

    Pittsburgh, Pennsylvania, United States TalentBurst, Inc. Full time

    Job Title: Specimen Processing SpecialistJob Summary: We are seeking a highly skilled Specimen Processing Specialist to join our team at TalentBurst, Inc. The ideal candidate will have a strong background in laboratory specimen processing and be able to work effectively in a fast-paced production environment.Key Responsibilities:Process and prepare...

  • Manufacturing Process Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States HotRun Inc. Full time

    HotRun Inc. is seeking a skilled Manufacturing Process Specialist to drive operational efficiencies and improve product quality. The ideal candidate will have a strong understanding of process control, project management, and lean manufacturing principles.Key Responsibilities:Develop and implement process improvements to increase efficiency and reduce...

  • Radiation Sterilization Validation Specialist

    1 week ago

    Pittsburgh, Pennsylvania, United States BGS US Full time

    BGS US, a leading provider of beta rays for radiation sterilization, is seeking a skilled Validation Engineer to join our team at our production facility in the US.This is a full-time position that requires a strong understanding of quality, radiation protection, and safety regulations. The ideal candidate will have experience in applications engineering,...

  • Manufacturing Process Improvement Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States EDAG, Inc. Full time

    Job OverviewEDAG Production Solutions is a leading provider of production plant planning, design, and optimization services. As a Manufacturing Process Improvement Specialist, you will play a key role in supporting the development of new manufacturing lines and ensuring their smooth operation.Key Responsibilities:Support process improvement initiatives to...

  • Senior Chemical Process Specialist

    1 week ago

    Pittsburgh, Pennsylvania, United States CPS Full time

    About the Role:CPS is seeking a highly skilled Chemical Process Specialist to join their team in the greater Pittsburgh area. As a key member of the operations team, you will be responsible for defining, evaluating, and executing site capital projects to improve performance.Key Responsibilities:Develop and manage project bids, budgets, and schedules for...

  • Process Optimization Specialist

    1 month ago

    Pittsburgh, Pennsylvania, United States TruFoodMfg Full time

    Job Title: Process EngineerWe are seeking a highly skilled Process Engineer to join our team at TruFoodMfg. As a Process Engineer, you will play a key role in driving process innovation and continuous improvement initiatives across our organization.Job SummaryThe successful candidate will be responsible for analyzing and implementing improvements to current...

  • Medicaid Process Liaison

    1 week ago

    Pittsburgh, Pennsylvania, United States Community LIFE Full time

    Job SummaryThe Medicaid Specialist is a critical role at Community LIFE, responsible for facilitating the Medicaid process and ensuring seamless communication between applicants, County Assistance Offices, and our team. This position requires strong analytical and interpersonal skills, with the ability to work effectively with diverse populations and...

  • Fulfillment Specialist

    1 week ago

    Pittsburgh, Pennsylvania, United States Walgreens Full time

    Job Summary: As a Fulfillment Specialist at Walgreens, you will be responsible for processing and shipping orders to customers for the centralized services pharmacy fulfillment center.Key Responsibilities:- Receive, scan, pick, pack, audit, and ship prescriptions to customers- Track all inbound and outbound items through radio frequency (RF) scanning- Verify...

  • Mortgage Processing Coordinator

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Timios, Inc. Career Page Full time

    Job Title: Processing SpecialistAt Timios, Inc., we are seeking a highly organized and detail-oriented Processing Specialist to join our team. As a key member of our operations team, you will play a critical role in ensuring the smooth execution of our real estate transactions.Key Responsibilities:Coordinate with borrowers, buyers, lenders, sellers,...

  • Process Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Xylem Full time

    Job Title: Process EngineerAt Xylem, we are seeking a highly skilled Process Engineer to join our team. As a Process Engineer, you will play a critical role in designing and documenting water treatment processes, working closely with cross-functional teams to develop innovative solutions.Key Responsibilities:Design and document water treatment processes,...

  • Mortgage Processing Coordinator

    1 week ago

    Pittsburgh, Pennsylvania, United States Timios, Inc. Career Page Full time

    Job OverviewAt Timios, Inc., we are seeking a highly skilled and detail-oriented Mortgage Processing Coordinator to join our team. As a key member of our processing team, you will be responsible for scheduling signings, assisting the Closing Specialist, and ensuring the smooth execution of real estate transactions.Key Responsibilities:Contact borrowers,...

  • Medical Device Software Verification and Validation Engineer

    7 days ago

    Pittsburgh, Pennsylvania, United States StarsHR, Inc. Full time

    StarsHR is seeking a highly skilled Medical Device Software Verification and Validation Engineer to join our client in Pittsburgh.Job Summary:The successful candidate will be responsible for the verification and validation of software for complex system interactions in medical devices.Key Responsibilities:Verification and validation of software for complex...

  • Payroll Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Prequel Solutions Full time

    Job DescriptionPrequel Solutions is seeking a skilled Payroll Specialist to join our team in the greater Pittsburgh area. This is a long-term contract position with a flagship financial services company, offering a hybrid working model and excellent benefits.As a Payroll Specialist, you will be responsible for payroll preparation, processing, reporting, and...

  • Manufacturing Process Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States HotRun Inc. Full time

    Job OverviewHotRun Inc. is seeking an experienced Manufacturing Engineer to join our team. As a key member of our operations team, you will be responsible for ensuring the efficient production of our products.Key ResponsibilitiesDevelop and implement process control strategies to improve manufacturing efficiencyCollaborate with cross-functional teams to...

  • Payroll Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Prequel Solutions Full time

    Job SummaryWe are seeking a skilled Payroll Specialist to join our team at Prequel Solutions. As a Payroll Specialist, you will be responsible for handling payroll preparation, processing, reporting, and reconciliation, ensuring accuracy and compliance across payroll systems.Key Responsibilities:Process payroll changes, invoices, and approvals.Reconcile...

  • Phlebotomy Specialist

    2 months ago

    Pittsburgh, Pennsylvania, United States Highmark Health Full time

    Job SummaryWe are seeking a skilled Phlebotomy Specialist to join our team at Highmark Health. As a Phlebotomy Specialist, you will be responsible for collecting and processing patient specimens in accordance with laboratory policies and procedures.Key ResponsibilitiesCollect and process patient specimens in a timely and efficient manner.Maintain a clean and...

  • Process Control Specialist

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Hunt Guillot & Associates Full time

    Job Summary:We are seeking a highly experienced Process Control Engineer to join our client's dynamic team at a major polymer manufacturing facility in the Pittsburgh, PA area.Candidates for this long-term, on-site role will have a strong background in instrumentation and control systems, particularly in large-scale industrial or chemical plant settings, and...

Process Validation Specialist

2 months ago

Pittsburgh, Pennsylvania, United States Krystal Biotech Full time
Job Overview

About Krystal Biotech:

At Krystal Biotech, we unite passionate and innovative individuals dedicated to the discovery, development, manufacturing, and commercialization of genetic therapies aimed at addressing critical health challenges. Established in 2016, Krystal stands out through our cutting-edge science and technology, utilizing a proprietary gene therapy platform, advanced manufacturing capabilities, and a unique approach to commercialization that prioritizes the patient experience.

Krystal has achieved a significant milestone with the U.S. FDA approval of VYJUVEK, the first and only redosable gene therapy for Dystrophic Epidermolysis Bullosa (DEB). We continue to leverage our innovative platform to advance a diverse pipeline of investigational genetic therapies across various fields, including respiratory, oncology, dermatology, and ophthalmology.

Headquartered in Pittsburgh, PA, we operate two state-of-the-art CGMP manufacturing facilities and maintain teams globally, with additional offices in Switzerland, Germany, and Japan. Our company culture is built on values of care, courage in the face of challenges, passion for our work, and unwavering scientific integrity. As we expand, we seek team members who embody these principles.

Position Summary:

Krystal Biotech is in search of a driven Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) to assist in the planning, design, and execution of process validation activities. This role will involve conducting risk assessments, implementing process enhancements, and managing various projects. The individual will also be integral to technology transfer initiatives, ensuring seamless transitions of processes across different sites.

Key Responsibilities:

  • Collaborate with Process Development and Manufacturing teams to maintain control over upstream and downstream processes.
  • Utilize Quality by Design (QbD) and traditional validation methodologies for both existing and new gene therapy products.
  • Conduct and document risk assessments to capture existing process knowledge and identify potential gaps.
  • Execute experiments at both bench and manufacturing scales to enhance process understanding and support development efforts.
  • Diagnose and resolve process and equipment challenges to optimize operational efficiencies.
  • Foster a culture of continuous improvement within processes and departments.
  • Create high-quality documentation that adheres to relevant standards and is suitable for its intended purpose.
  • Contribute to the development of new manufacturing facilities to ensure effective technology and process transfers.
  • Collaborate with CMC counterparts to prepare materials for regulatory review.

Minimum Qualifications & Desired Skills:

  • Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or a related field.
  • Relevant validation and/or engineering experience in the Biotech or Pharmaceutical sector (1+ years for Associate, 3+ years for Engineer level).
  • Knowledge and experience in GMP, GLP, and statistical analysis.
  • Strong understanding of GMP and ICH guidelines, as well as QbD principles.
  • Prior experience in the gene therapy sector is preferred.
  • Self-motivated with the ability to work independently with minimal supervision.
  • Capable of managing multiple responsibilities in a dynamic and fast-paced environment, with effective prioritization skills.
  • Excellent verbal and written communication abilities.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employer. Qualified candidates will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this website or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

Powered by JazzHR

dQPA6kNbJo