pharma validation engineer Jobs

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Software Engineer, Thermal Systems Validation

Tesla Motors

Palo Alto, California, USA

Full-time

Tesla is looking for a highly motivated individual to join the Vehicle Software organization's Systems Validation Team with a focus on HVAC controls and UI. This team is responsible for validating all software driven, system level, vehicle requirements prior to any new hardware or software release or new product introduction. As a Systems Validation Engineer you are expected to be an expert in your domain, have a deep understanding of the software/hardware dependencies of your system, and ensure

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

Raleigh, North Carolina, USA

Full-time

Piper Companies is actively seeking a Cleaning Validation Engineer to join our team at a new manufacturing facility. The successful candidate will play a critical role in the development, implementation, and maintenance of cleaning validation processes, ensuring compliance with GMP standards and regulatory requirements. This is a Monday - Friday, traditional hours role located in the greater Raleigh, NC area. Responsibilities of the Cleaning Validation Engineer: Develop and execute cleaning val

Analytical Validation Engineer

Zachary Piper Solutions, LLC

Hopewell Township, New Jersey, USA

Full-time

Piper Companies is looking for an Analytical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company in the Titusville, NJ area. Responsibilities for the Analytical Validation Engineer include: Experience in Pharmaceutical Laboratory Operations Must be familiar and have experience with laboratory instrument selection, installation (IQ/OQ) and qualification (PQ) Experience supporting laboratory investigations from beginning to end, includ

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

Holly Springs, North Carolina, USA

Full-time

Piper Companies is seeking a Cleaning Validation Engineer to join a growing leader in the pharmaceutical/biotechnology space for an onsite position in Holly Springs, North Carolina (NC) . The Cleaning Validation Engineer will play a critical role in the development, implementation, and maintenance of cleaning validation processes for our new manufacturing facility. This position requires a thorough understanding of cleaning validation principles, regulatory requirements, and industry best prac

Validation Engineer

Zachary Piper Solutions, LLC

Lynwood, California, USA

Full-time

Piper Companies is looking for a Pharmaceutical Validation Engineer to support commissioning and decommissioning activities for a major pharmaceutical company in the Los Angeles County area. Responsibilities for the Validation Engineer include: Experience in Pharmaceutical Laboratory Operations Proficiency with cleaning validation as this is a multi-product production space Must be familiar and have experience with laboratory and manufacturing instrument selection, installation (IQ/OQ) and qua

Validation Engineer

Zachary Piper Solutions, LLC

Holly Springs, North Carolina, USA

Full-time

We are seeking an experienced Validation Engineer to support the qualification and validation of filling equipment at our biologics CDMO. The ideal candidate will have a strong background in validation, particularly with filling devices, and be able to effectively communicate and coordinate with various teams, including QC labs, material science, and operations. Responsibilities of the Validation Engineer: Conduct Aseptic Process Simulation (APS) by filling media to promote growth, incubating c

Cleaning Validation Engineer

Zachary Piper Solutions, LLC

Holly Springs, North Carolina, USA

Full-time

Piper Companies is looking for a Cleaning Validation Engineer that will play a critical role in the development, implementation, and maintenance of cleaning validation processes for a brand new manufacturing facility. This position requires a thorough understanding of cleaning validation principles, regulatory requirements, and industry best practices. The successful candidate will ensure that all cleaning procedures are validated and compliant with GMP standards. Responsibilities of the Cleani

Wireless RF OTA Connectivity Validation Engineer

Apple, Inc.

No location provided

Full-time

At Apple, we work every single day to craft products that enrich people's lives. Do you love working on challenges that no one has solved yet? Do you like changing the game? As a member of our dynamic group, you will have the unique and rewarding opportunity to shape upcoming products that will delight and inspire millions of Apple's customers every day. Apple's Wireless System Engineering team is looking for an engineer to work on radiated system characterization across different connectivity t

Validation Engineer

Katalyst Healthcares and Lifesciences

Norwood, Massachusetts, USA

Full-time

Roles and Responsibilities: BS degree minimum. 5 years of Validation Engineering experience in pharmaceutical industry. Strong skill set in installation and IQOQ of equipment like centrifuges, filter presses, and processing tanks. Very strong technical writing/documentation skills. Very strong communication skills and ability to coordinate with cross-functional teams. Experience doing job walks with engineers for capital projects. Must have a positive attitude and ability to multi-task.

Sr. Process Validation Engineer

Katalyst Healthcares and Lifesciences

Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Minimum 7 years of CQV experience in a parenteral fill/finish environment. Lead process validation projects of broad scope. Responsible for project deliverables such as VMPs, pFMEAs, PPQ protocols and reports, change control assessments, technical transfer assessments, as well as other client deliverables as required. Provide technical support to Manufacturing - troubleshooting and resolving process related issues. Participate in investigations and provide documentation

Validation Engineer

Katalyst Healthcares and Lifesciences

Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to

Lab Validation Engineer

Katalyst Healthcares and Lifesciences

Tarrytown, New York, USA

Full-time

Responsibilities: CM is looking for candidates that have experience with laboratory equipment qualifications, writing life cycle documents, drafting deviations, and are familiar with part 11 and DIA. A big part of this role is knowing the DIA (Data Integrity Assessment part 11) Knowing how to write an IOQ and execute it. IF they can do that the CM thinks they can cross over to other areas and can use that in both fill/finish and lab equipment. Please understand that this is an on-the-floor job.

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

Validation Engineer

Katalyst Healthcares and Lifesciences

Springfield, Illinois, USA

Full-time

Job summary: Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities. Responsibilities: Lead facility commissioning activities across multiple sites. Conduct temperature and humidity mapping studies. Perform cleanroom validation for Class 6, 7, and 8 envi

Validation Engineer III

Katalyst Healthcares and Lifesciences

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot

Validation Engineer

Katalyst Healthcares and Lifesciences

Tarrytown, New York, USA

Full-time

Responsibilities: Validation & Qualification: Perform and support IQ/OQ for new fill-finish equipment and filling lines. Ensure that all equipment is installed and operating according to design specifications and regulatory standards. Commissioning Support: Assist with the commissioning of new equipment, ensuring all systems and equipment function properly before starting the qualification process. Documentation: Prepare, review, and maintain detailed validation protocols, reports, and document

Validation Engineer

Katalyst Healthcares and Lifesciences

Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and

Validation Engineer

Katalyst Healthcares and Lifesciences

Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functi

Validation Engineer

Katalyst Healthcares and Lifesciences

Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functional

Sr Validation Engineer

Katalyst Healthcares and Lifesciences

Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute