Validation Engineering Specialist
3 weeks ago
PSC Biotech is a leading provider of life sciences services, ensuring that healthcare products meet the highest standards of quality and compliance. We are seeking an experienced Validation Engineer to support our commissioning, qualification, and validation projects.
About the RoleWe are hiring a skilled Validation Engineer to develop and execute IQ, OQ, PQ, and PV protocols for pharmaceutical manufacturing equipment, facilities, utilities, and associated systems. The successful candidate will contribute to the development of master plans and validation strategies, adhering to regulatory requirements and compliance standards.
Responsibilities- Develop and execute validation protocols, test methods, procedures, reports, risk assessments, and other related documents.
- Collaborate with cross-functional teams to ensure alignment and successful completion of validation activities and deliverables.
- Perform risk assessments and support risk mitigation strategies, investigate and review deviations, and efficiently close them.
- Provide support for regulatory inspections as needed, and identify potential risks/issues throughout the validation lifecycle.
- Bachelor's degree in a relevant engineering discipline.
- 5+ years of experience in equipment commissioning, qualification, and validation engineering, including proven success developing and executing validation protocols in the pharmaceutical manufacturing industry.
- In-depth knowledge of regulatory requirements and guidelines, including cGMP, FDA, etc.
- Excellent technical writing skills, with 5+ years of experience drafting, developing, reviewing, and authorizing technical documentation.
- Strong understanding of engineering specifications (URS, DS, FS, etc.) and detail-oriented with a focus on accuracy and compliance.
- Estimated salary: $120,000 - $150,000 per year.
-
Computer System Validation Specialist
3 weeks ago
Rockville, Maryland, United States Supernus Pharmaceuticals Full timeAbout the Role:This position involves performing Computer System Validation activities for GAMP5 Category 3/4/5 GxP systems and software qualification of GAMP5 Category 1 tools.Key Responsibilities:Generate and execute validation documents, including Requirement Specifications, Risk Assessments, Traceability Matrices, Validation Plans, and reports.Develop...
-
Computer Systems Validation Lead Specialist
3 weeks ago
Rockville, Maryland, United States Quality Agents Full timeJob Title: Computer Systems Validation Lead SpecialistOverview: Quality Agents is a leading provider of validation and quality expertise to the pharmaceutical and biotechnology industries. Our team offers a unique combination of technical expertise and industry knowledge to support our clients' computer systems validation needs.Responsibilities: We are...
-
Validation Expert
3 weeks ago
Rockville, Maryland, United States PSC Biotech Full timePSC Biotech offers a unique opportunity for talented professionals to join its team as a Validation Engineer. With operations spanning the globe, we are passionate about bringing the best and brightest together to form something truly special. As a Validation Engineer, you will be responsible for driving project success by supporting validation planning,...
-
Validation Expert
3 weeks ago
Rockville, Maryland, United States PSC Biotech Full timeCompany OverviewPSC Biotech is a leading provider of life sciences services, committed to ensuring the highest standards of quality and regulatory compliance in the industry. Our global team of experts spans across strategically located offices in North America, Europe, Asia, and the Middle East.We strive to deliver exceptional results for our clients,...
-
Pharmaceutical Validation Professional
3 weeks ago
Rockville, Maryland, United States Supernus Pharmaceuticals Full timeAbout the RoleWe are seeking a highly skilled Pharmaceutical Validation Professional to join our team at Supernus Pharmaceuticals.This is an exciting opportunity for someone with a strong background in computer system validation and GxP systems.The successful candidate will be responsible for performing activities related to the Computer System Validation...
-
Senior Computer System Validator
3 weeks ago
Rockville, Maryland, United States Quality Agents Full timeAbout the RoleThe Computer Systems Validation Lead will contribute to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.Key Responsibilities:Optimization...
-
Cloud Engineer Specialist
3 weeks ago
Rockville, Maryland, United States Global Alliant Inc Full time**Job Title:** Cloud Engineer Specialist**Company Overview:** Global Alliant, Inc. is a leading provider of innovative solutions.**Salary:** Up to $130,000 per year, based on experience and qualifications.**Job Description:The DevOps/SecOps Engineer will work with modern cloud infrastructure and CI workflow automation. Key responsibilities include building...
-
Engineering Support Specialist
4 weeks ago
Rockville, Maryland, United States Bienvivir All Inclusive Health Full timeWe are seeking a highly skilled Engineering Support Specialist to join our team at Bienvivir All Inclusive Health. This is an exciting opportunity for someone who wants to take on a challenging role and make a real impact in the construction industry.The successful candidate will have a strong understanding of engineering principles and practices, including...
-
Commercial Solar Engineering Specialist
3 weeks ago
Rockville, Maryland, United States Standard Solar Full timeStandard Solar seeks a talented Commercial Solar Engineering Specialist to join our team. As a key member of our engineering team, you will play a crucial role in designing and implementing commercial-scale solar electric systems.Responsibilities:Lead the design and implementation of commercial solar PV systems, including system design, permitting, and...
-
Senior Engineering Content Specialist
3 weeks ago
Rockville, Maryland, United States Links Global Full timeJob OverviewA senior engineering content specialist with a strong background in engineering is needed to create exceptional technical documentation for multiple audiences. This role involves collaborating with engineers, subject matter experts, and product managers to grasp intricate engineering concepts.Key ResponsibilitiesCraft clear, concise, and...
-
Software Development Engineer in Test Specialist
3 weeks ago
Rockville, Maryland, United States Indotronix International Corporation Full time**Job Title:** Software Development Engineer in Test Specialist**Location:** Rockville, MD (Remote)We are seeking an experienced Software Development Engineer in Test Specialist to join our team at Indotronix International Corporation. The ideal candidate will have a strong background in software development and testing, with a focus on...
-
Enterprise Solutions Manager
3 weeks ago
Rockville, Maryland, United States Skylla Engineering Full timeAbout Skylla EngineeringSkylla Engineering is the largest general contractor that solely serves the MidAtlantic region. We value diversity and are committed to building a workplace where our employees are provided the necessary support to be successful.We have an exciting opportunity for an Enterprise Solutions Manager to lead our team responsible for...
-
Transportation Infrastructure Specialist
4 days ago
Rockville, Maryland, United States AMT Engineering Full timeAbout the Position: We are seeking a highly skilled Transportation Project Manager to lead multidiscipline teams in delivering transportation design projects. The ideal candidate will serve as a liaison between clients and project teams, managing technical resources, preparing task proposals, and establishing project pricing and budgets. Key...
-
Mobile Mechanic Specialist
3 weeks ago
Rockville, Maryland, United States RMA Worldwide Transportation Full timeJob SummaryWe are seeking an experienced Mobile Mechanic Specialist to join our team at RMA Worldwide Transportation. As a Mobile Mechanic Specialist, you will be responsible for performing preventative maintenance and minor repairs on our fleet of vehicles.The ideal candidate will have at least 3 years of experience in automotive repair and maintenance, as...
-
Digital Engineering Professional
4 weeks ago
Rockville, Maryland, United States Lockheed Martin Corporation Full timeAbout Lockheed MartinWe're a global aerospace and defense company with a rich history of innovation and achievement. Our mission is to protect and defend national interests while pushing the boundaries of science and technology.We're committed to creating a culture that values diversity, equity, and inclusion. Our employees are our greatest asset, and we...
-
Key Account Solutions Specialist
2 days ago
Rockville, Maryland, United States PSC Biotech Full timeCompany OverviewPSC Biotech is a life sciences consulting firm that provides essential services to ensure the development, manufacture, and distribution of health care products meet the highest standards.We focus on delivering quality consulting services that drive our clients' success. Our cost-effective solutions are backed by exceptional technical...
-
Verification Systems Specialist
4 days ago
Rockville, Maryland, United States Disability Solutions Full timeAbout the Role: We are seeking a skilled Verification Systems Specialist to join our team in McLean, Virginia. As a key member of our Intelligence & Security division, you will play a critical role in guiding and determining the verification approach for our Systems Engineering team as it incorporates Model Based Systems Engineering (MBSE) tools and...
-
Engineering Solutions Specialist
5 days ago
Rockville, Maryland, United States JENSEN HUGHES Full time**Consulting Engineer Role:**Jensen Hughes is seeking a skilled Consulting Engineer to support regulatory compliance and risk assessment needs within the nuclear industry.The ideal candidate will have a strong background in Probabilistic Risk Analysis (PRA) or other risk-based projects, as well as prior experience in PRA internal events, fire PRA, external...
-
Data Engineering Specialist
3 weeks ago
Rockville, Maryland, United States GEI Consultants Full timeWe are seeking a highly skilled Data Engineer to join our team at GEI Consultants. As a Data Engineer, you will play a crucial role in designing, managing, and supporting MS SQL Server and Azure databases.About the RoleThis is an exciting opportunity to work on a variety of systems and data engineering tasks focused on data flow activities. You will...
-
Automotive Technician Specialist
4 days ago
Rockville, Maryland, United States AutoNation Full timeJob Summary: As an Automotive Technician Specialist at AutoNation, you will be responsible for inspecting and servicing vehicles to ensure they meet our high standards. Our team of experts is committed to providing exceptional service to our customers, and we are seeking a skilled technician to join our ranks.About the Role: In this role, you will inspect...