Senior Validation Engineer
7 days ago
About PSC Biotech Corporation
PSC Biotech Corporation is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and compliance in the development, manufacturing, and distribution of healthcare products.
Job Summary
We are seeking an experienced Validation Project Manager to join our team. The successful candidate will have a strong technical background in equipment and system validation, as well as excellent communication, organization, and project coordination skills.
Key Responsibilities
- Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
- Generate and manage project deliverables, preventative maintenance coordination, and risk mitigation.
- Define and monitor Key Performance Indicators (KPIs) to measure validation effectiveness and report on KPIs to management and stakeholders.
- Oversee validation projects from initiation to completion.
- Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
- Conduct dry-runs, review, approve, and execute validation documentation.
- Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
- Implement and review audit trails to ensure data integrity.
- Provide ongoing support and technical expertise through validation execution and qualification activities.
- Conduct risk analyses and identify potential risks, recommending areas of improvement.
- Design, develop, and optimize terminal sterilization cycles for pharmaceutical products.
- Identify, document, and manage deficiencies and deviations.
- Perform risk assessments to identify critical process parameters and develop mitigation strategies.
- Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.
Requirements
- Bachelor's degree in a related engineering discipline.
- 8+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
- Strong knowledge of terminal sterilization processes, cycle development, performance qualification, and process qualification preferred.
- Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
- Experienced in generating and executing validation activities on a range of equipment and systems.
- Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
- Experienced in vendor coordination.
- Excellent technical writing skills.
- Strong understanding of industry regulations and requirements.
- Strong attention to detail and commitment to quality and compliance.
- Strong problem-solving and analytical skills.
Benefits
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents.
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching.
- PTO, Sick Time, and Paid Holidays.
- Education Assistance.
- Pet Insurance.
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
- Financial Perks and Discounts.
Equal Opportunity Employment Statement
PSC Biotech Corporation is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
-
Validation Engineering Lead
2 weeks ago
Durham, North Carolina, United States PSC Biotech Full timeBecome a Key Player as a Validation Project CoordinatorPSC Biotech stands at the forefront of providing vital services to the life sciences sector, ensuring that the creation, production, and distribution of healthcare products adhere to regulatory standards. Our worldwide team of experts is committed to upholding high-quality benchmarks and facilitating our...
-
Validation Process Engineer
2 weeks ago
Durham, North Carolina, United States Katalyst Healthcares and Life Sciences Full timePosition Overview: As a key member of Katalyst Healthcares and Life Sciences, the Validation Process Engineer will play a crucial role in ensuring the integrity and compliance of our manufacturing processes. Key Responsibilities: Validation Strategy Development: Formulate and execute comprehensive validation strategies for processes, equipment, and cleaning...
-
Validation Engineer
7 days ago
Durham, North Carolina, United States MedPharm (formerly Tergus Pharma) Full timeAbout the RoleAs a Validation Engineer at MedPharm (formerly Tergus Pharma), you will play a critical role in ensuring the quality and integrity of our pharmaceutical development and manufacturing operations.Key ResponsibilitiesSite Master Validation Program: Provide input and administration of the site master validation program, assist in maintaining the...
-
Validation Operations Manager
1 week ago
Durham, North Carolina, United States PSC Biotech Corporation Full timeJoin the Team at PSC Biotech CorporationWe are seeking a skilled Validation Project Manager to become a vital part of our international team. In this position, you will take charge of formulating and executing validation strategies, protocols, and documentation for various equipment, processes, and systems. You will manage validation initiatives from their...
-
Validation Project Lead
2 weeks ago
Durham, North Carolina, United States PSC Biotech Corporation Full timeJoin the PSC Biotech Team as a Validation Project ManagerWe are seeking a skilled Validation Project Manager to be part of our dynamic global team. In this pivotal role, you will take charge of crafting and executing validation strategies, including plans, protocols, and documentation for various equipment, processes, and systems. You will manage validation...
-
CQV Engineer
5 days ago
Durham, North Carolina, United States Verista Full timeJob DescriptionAt Verista, we are a leading provider of innovative solutions and services to the life science industry. Our team of experts is dedicated to empowering growth and innovation within the scientific community, and we are seeking a highly skilled CQV Engineer to join our team.Key Responsibilities:Collaborate with clients' quality representatives...
-
Senior Integration Solutions Engineer
2 weeks ago
Durham, North Carolina, United States Crescens Full timeJob Title: Senior Integration Solutions Engineer Company: Crescens Duration: 12+ months Type: ContractOverview: Crescens is seeking a proficient Senior Integration Solutions Engineer to manage, design, and implement integration solutions utilizing the MuleSoft Anypoint Platform.Detailed Job Description: The organization requires highly skilled...
-
Validation Program Manager
2 weeks ago
Durham, North Carolina, United States PSC Biotech Full timeBecome a Key Player as a Validation Program ManagerPSC Biotech stands at the forefront of delivering vital services to the life sciences sector, ensuring that the development, production, and distribution of healthcare products comply with regulatory standards. Our worldwide team of experts is committed to achieving high-quality outcomes and facilitating our...
-
Manufacturing Validation Specialist
2 weeks ago
Durham, North Carolina, United States Katalyst Healthcares and Life Sciences Full timePosition Overview: Join Katalyst Healthcares and Life Sciences as a Process/Validation Engineer, where you will play a crucial role in ensuring the integrity and compliance of our manufacturing processes.Key Responsibilities:Validation Strategy Development: Formulate and execute validation strategies for processes, equipment, and cleaning protocols, adhering...
-
Senior Frontend Engineer
2 weeks ago
Durham, North Carolina, United States American Unit, Inc Full timeSenior Frontend EngineerContract PositionRemote OpportunityPosition OverviewAmerican Unit, Inc. is seeking a skilled Senior Frontend Engineer to collaborate with our esteemed healthcare partner. This role involves engaging in various projects and ensuring that user requirements are fulfilled through the design, development, documentation, and testing of both...
-
Senior Mechanical Engineer for Automated Systems
2 weeks ago
Durham, North Carolina, United States BioFire Diagnostics Full timePosition Overview:As a Senior Mechanical Engineer, you will play a crucial role in the engineering and maintenance of highly automated packaging systems. This position is essential for ensuring that our manufacturing facility produces high-quality products that comply with all relevant regulatory standards and meet global customer needs.Key...
-
Validation Specialist
4 days ago
Durham, North Carolina, United States MedPharm (formerly Tergus Pharma) Full timeJob SummaryMedPharm (formerly Tergus Pharma) is seeking a highly skilled Validation Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for providing direct validation support to our pharmaceutical development and manufacturing operations.Key ResponsibilitiesSite Master Validation ProgramDevelop and...
-
Senior Applications Engineering Specialist
2 weeks ago
Durham, North Carolina, United States Synopsys Full timeApplications Engineering OverviewAt Synopsys, we are at the forefront of technological advancements that transform our daily lives. From autonomous vehicles to cutting-edge AI, our innovations are shaping the future. We are dedicated to delivering the most sophisticated technologies for chip design and software security, driving the Era of Smart...
-
Senior Process Engineering Leader
2 weeks ago
Durham, North Carolina, United States Elo Life Systems Full timePOSITION OVERVIEWReporting directly to the Senior Vice President of Global Manufacturing, Operations, and Regulatory Affairs, the Senior Process Engineering Leader will play a pivotal role within the Manufacturing division. This position is tasked with the development and oversight of Elos pilot initiatives, collaborating closely with Research and...
-
Senior Reliability Engineer I
2 weeks ago
Durham, North Carolina, United States Biogen Full timeAbout This Position The Senior Reliability Engineer I plays a crucial role in enhancing the reliability and performance of essential assets within the organization. This position involves the application of advanced Reliability Engineering principles to ensure optimal design specifications and operational efficiency. Key Responsibilities: Develop and...
-
Lead Validation Project Coordinator
1 week ago
Durham, North Carolina, United States PSC Biotech Corporation Full timeJoin the Team at PSC Biotech CorporationWe are seeking a skilled Validation Project Manager to be part of our international team. In this pivotal role, you will take charge of formulating and executing validation strategies, protocols, and documentation for various equipment, processes, and systems. You will manage validation initiatives from start to...
-
Senior Process Engineering Specialist
2 weeks ago
Durham, North Carolina, United States FUJIFILM Holdings America Corporation Full timeOverview The Senior Process Engineering Specialist serves as a key representative of the technical operations division at FUJIFILM Holdings America Corporation, engaging with clients, regulatory bodies, and internal management. This role is pivotal in overseeing the integration of new client processes and ensuring that project goals are met effectively. The...
-
Validation Specialist
7 days ago
Durham, North Carolina, United States DPS Group LLC Full timeAbout the RoleWe are seeking a highly skilled Validation Specialist to join our team at DPS Group LLC. As a key member of our team, you will be responsible for ensuring the quality and integrity of our projects.Key ResponsibilitiesProvide support for Commissioning and Qualification activities for our clientsAuthor and execute Commissioning and Qualification...
-
Specialist, Validation
1 month ago
Durham, North Carolina, United States Merck Full timeJob DescriptionGENERAL INFORMATIONWe have an exciting opportunity for a Validation Specialist to join the technical operations team for a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, component preparation areas, harvest, filling,...
-
Durham, North Carolina, United States Cisco Full timeAbout the RoleThe Security Visibility and Validation (SVV) Team is part of the Security Engineering department within the Security and Trust Organization (S&TO). Our team works to strengthen Cisco's approach to security by developing software tools and solutions for meaningful risk reductions in our products and to protect the Cisco brand.Key...