Validation Engineer

2 weeks ago

Warminster, United States Joulé Full time

Title: Automation Validation Engineer - Pharmaceutical
Location: Warminster, PA
Type: 6 Month Contract potential for extension or hire
Schedule: Mon-Fri Day

Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develop and execute validation plans and tests for new pharma processing equipment. The ideal candidate will have a strong background in validation methodologies, experience in the pharmaceutical industry, and experience crafting processes and validation protocols.

Responsibilities: Develop and execute validation protocols for pharmaceutical equipment, including systems and software validation, in accordance with regulatory requirements such as FDA, EU GMP, and ISO standards.
Collaborate with cross-functional teams including engineering, quality assurance, and regulatory affairs to ensure validation activities are completed effectively and efficiently.
Perform risk assessments to identify potential hazards and develop mitigation strategies for validation activities.
Conduct testing and analysis to verify that equipment meets performance specifications and functional requirements.
Generate comprehensive validation documentation, including protocols, reports, and traceability matrices, ensuring accuracy and compliance with regulatory standards.
Provide support during regulatory inspections and audits by presenting validation documentation and addressing any inquiries related to validation activities.
Stay informed about industry trends and regulatory changes related to validation practices and implement best practices to continuously improve validation processes.


Qualifications: Bachelor's degree in engineering, pharmaceutical sciences, or related field; advanced degree preferred.
Minimum of 5 years of experience in developing validation plans and protocols within the pharmaceutical industry, preferably in equipment manufacturing or OEM environment.
Strong understanding of regulatory requirements for pharmaceutical validation, including FDA 21 CFR Part 11, EU Annex 11, and GAMP guidelines.
Proficiency in validation methodologies such as IQ/OQ/PQ, risk assessment, and validation lifecycle management.
Experience with validation of complex systems and software applications used in pharmaceutical equipment.
Excellent analytical and problem-solving skills, with the ability to troubleshoot technical issues and propose effective solutions.
Exceptional communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders.
Detail-oriented with a commitment to producing high-quality validation documentation that meets regulatory standards.
Ability to work independently with minimal supervision and manage multiple projects simultaneously


#LI-MD1
#M3

  • Validation Engineer

    2 weeks ago

    Warminster, United States Joulé Full time

    Title: Automation Validation Engineer - Pharmaceutical Location: Warminster, PA Type: 6 Month Contract potential for extension or hire Schedule: Mon-Fri Day Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develop and execute validation plans and tests for new pharma processing equipment. The ideal...

  • Senior Validation Engineer

    2 weeks ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with ExperienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.You will collaborate with Process and Quality Engineers to draft and execute process validation...

  • Validation Engineer

    6 days ago

    Warminster, PA, United States Joulé Full time

    Title: Automation Validation Engineer - Pharmaceutical Location: Warminster, PA Type: 6 Month Contract potential for extension or hire Schedule: Mon-Fri Day Overview: Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develop and execute validation plans and tests for new pharma processing equipment. The ideal...

  • Senior Systems Engineer

    2 weeks ago

    Warminster, United States MVG | Microwave Vision Group Full time

    At Orbit Advanced Technologies, Inc., (OATI), a division of MVG, we strive to deliver the most advanced antenna and RCS measurement facilities to the U.S. aerospace and defense industry. OATI is seeking driven individuals who excel in fast-paced environments, moving novel concepts from inception to commissioning. We welcome candidates who will bring...

  • Senior Systems Engineer

    2 weeks ago

    Warminster, United States MVG | Microwave Vision Group Full time

    At Orbit Advanced Technologies, Inc., (OATI), a division of MVG, we strive to deliver the most advanced antenna and RCS measurement facilities to the U.S. aerospace and defense industry. OATI is seeking driven individuals who excel in fast-paced environments, moving novel concepts from inception to commissioning. We welcome candidates who will bring...

  • Senior Systems Engineer

    3 weeks ago

    Warminster, United States MVG | Microwave Vision Group Full time

    At Orbit Advanced Technologies, Inc., (OATI), a division of MVG, we strive to deliver the most advanced antenna and RCS measurement facilities to the U.S. aerospace and defense industry. OATI is seeking driven individuals who excel in fast-paced environments, moving novel concepts from inception to commissioning. We welcome candidates who will bring...

  • Senior Systems Engineer

    2 weeks ago

    Warminster, United States MVG | Microwave Vision Group Full time

    At Orbit Advanced Technologies, Inc., (OATI), a division of MVG, we strive to deliver the most advanced antenna and RCS measurement facilities to the U.S. aerospace and defense industry. OATI is seeking driven individuals who excel in fast-paced environments, moving novel concepts from inception to commissioning. We welcome candidates who will bring...

  • MES Engineer

    2 weeks ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: commensurate with experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. We are seeking to hire an Enterprise Implementation / MES Engineer. The ideal candidate has...

  • MES Engineer

    3 weeks ago

    Warminster, United States MRINetwork Jobs Full time

    Job DescriptionJob DescriptionOur Client - A rapidly growing Medical Device Manufacturing company needs an ERP Implementation – MES Engineer for a permanent, full-time position at their plant in PA near Philadelphia. Excellent Salary + Long Term Stock Options + Relocation + Full Benefits + Flextime. Job Posting # 2634 Job Title: MES Engineer – ERP...

  • MES Engineer

    5 days ago

    Warminster, United States MRINetwork Jobs Full time

    Job DescriptionJob DescriptionOur Client - A rapidly growing Medical Device Manufacturing company needs an ERP Implementation – MES Engineer for a permanent, full-time position at their plant in PA near Philadelphia. Excellent Salary + Long Term Stock Options + Relocation + Full Benefits + Flextime. Job Posting # 2634 Job Title: MES Engineer – ERP...

  • Manufacturing Engineer: Electronic Device Manufacturing

    1 month ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: Commensurate with experienceAbout:LifeLens Technologies, Inc. is a medical device developer located in Warminster, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring.​We are hiring a Manufacturing Engineer: Electronic Device Assembly. The ideal candidate is a self-starter...

  • Documentation Specialist

    3 weeks ago

    Warminster, United States LifeLens Technologies Inc. Full time

    Job DescriptionJob DescriptionSalary: $28.00 - $35.00 / hr depending on experienceLifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative next-generation treatment devices for personal health monitoring. JOB SUMMARY:The Engineering Documentation Specialist is responsible for taking...

  • Document Specialist

    2 weeks ago

    Warminster, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Science is seeking a Documentation Specialist for a growing medical device manufacturer located near Warminster, PA.Salary: $28-38/hour depending on experienceShift: Monday- Friday 8am-4:30pm Employment Type: Full Time; Direct HireSummary: As the Documentation Specialist, you will be responsible for taking complex technical information and translating...