Cleaning Validation Engineer

2 weeks ago

Novato, United States Pharmatech Associates Full time

* We all contribute to the success of our clients. Your input will be heard, encouraged and valued.

* As a consultant with Pharmatech you will gain invaluable experience from project to project.

* Your coworkers are a group of highly intelligent and motivated leaders. There will always be someone to learn from.

* We take great pride in offering competitive compensation packages to attract top talent.

* No internal politics A culture that thrives on true collaboration.

Location Novato, CA

We are looking for a **Cleaning Validation Engineer** to join our consulting team and provide market leadership to the Life Science industry. This is a 6 12 month contract position located in Novato, CA

* Design and coordinate cleaning validation activities.

* Prepare and execute protocols and reports for cleaning development and validation.

* Perform investigation of deviations / discrepancies.

**Job Functions**

* Design and develop cleaning validation protocols for products and manufacturing equipment, including steaming studies

* Provide technical support to cleaning activities associated with the manufacturing process.

* Develop a strong documentation package, involving pre-commissioning/commissioning of equipment, Qualification and documentation

* Support cleaning validation program and activities, including re-validation and validation discrepancy reports

* Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.

* Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures.

* Supports the establishment and/or enhancement of cleaning practices.

* Reviews and approves Manufacturing Cleaning Working Instructions and Forms.

* Supports the periodic review of cleaning validation studies.

* Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.

* Issues Change Controls required for the implementation of cleaning procedure changes, as needed.

* Trains manufacturing and QC/QA personnel on cleaning validation documentation.

**Qualifications**

* Bachelor's in Science, Engineering or related discipline plus 5 years of professional experiences in cleaning validation in the pharmaceutical and/or biotechnology industries.

* Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.

* Fluent in drafting and executing re-validation protocols and validation discrepancy reports required

* Ability to design and develop cleaning validation protocols for products and manufacturing equipment, including steaming studies/procedures is required

* Proficient time management skills, planning and organization capabilities.

* Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.

* Proven assessment, analytical and problem-solving skills.

* Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.

*Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.*

  • Principal Automation Engineer

    Found in: beBee S US - 3 weeks ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Automation Engineer, Delta V

    Found in: beBee S US - 2 weeks ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Automation Engineer, Delta V

    Found in: beBee jobs US - 2 weeks ago

    Novato, California, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...

  • Automation Engineer, Delta V

    24 hours ago

    Novato, United States BioMarin Pharmaceutical Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Sr. Automation Engineer, Delta V

    Found in: beBee S US - 6 days ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Sr. Automation Engineer, Delta V

    Found in: beBee jobs US - 3 weeks ago

    Novato, California, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...

  • Automation Engineer, Delta V

    2 weeks ago

    Novato, United States Biomarin Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Automation Engineer, Delta V

    1 week ago

    Novato, United States CareerBuilder Full time

    Who We Are BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality...

  • Sr. Engineer 2, C&Q

    Found in: beBee S US - 3 weeks ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Sr. Engineer 2, C&Q

    Found in: beBee S US - 2 weeks ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Sr. Project Engineer 2

    Found in: beBee S US - 3 weeks ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Sr. Project Engineer 2

    Found in: beBee jobs US - 3 weeks ago

    Novato, California, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...

  • Project Engineer 2

    2 weeks ago

    Novato, United States Biomarin Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Project Engineer 2

    5 days ago

    Novato, United States CareerBuilder Full time

    Who We Are BioMarins Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarins cutting-edge manufacturing processes and sites, provide quality assurance and quality...

  • Mitigation Technician

    3 weeks ago

    Novato, United States DRYmedic North BayEast Bay, CA Full time

    Job DescriptionJob DescriptionBenefits/PerksCareer Advancement OpportunitiesCompetitive CompensationHealth InsurancePaid Time OffCompany OverviewDRYmedic Restoration Services is a team of experienced disaster restoration professionals. Our technicians use industry-leading equipment and trusted techniques to restore your property after water, fire, mold, or...

  • Mitigation Technician

    2 days ago

    Novato, United States DRYmedic North BayEast Bay, CA Full time

    Job DescriptionJob DescriptionBenefits:Dental insuranceHealth insurancePaid time offTraining & developmentVision insuranceBenefits/PerksCareer Advancement OpportunitiesCompetitive CompensationHealth InsurancePaid Time OffCompany OverviewDRYmedic Restoration Services is a team of experienced disaster restoration professionals. Our technicians use...

  • EMT Basic

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Novato, United States AMR Corp. Full time

    Located in Napa, CAMore Information about this Job: IMMEDIATELY HIRING! EMT FULL-TIME Opportunity LOCATION: Napa, CaWe're hiring Emergency Medical Technicians (EMT s) that will respond to emergency and non-emergency requests for medical assistance and deliver high-quality care , treatment and customer service to patients. Responsibilities: EMTs p rovide an...

  • Personal Attendant

    2 weeks ago

    Novato, United States Pathway to Choices, Inc. Full time $18

    Pathway to Choices, IncJOB DESCRIPTION:Position Title: PERSONAL ATTENDANT.Responsible to: Program Coordinator.Supervises: None.Classification: Exempt.Work Hours:$18.00 awake hours, $17.00 per hour for overnight shifts.Medical and Dental Benefits after 90 days of Employment.Open shifts are Saturday 8:00 am to 4:00 p, 4:00 until midnight and midnight until...

  • Associate Director, Clinical Supply Gene Therapy

    1 day ago

    Novato, United States Ultragenyx Pharmaceuticals Inc. Full time

    Position Summary: ultrafocused - Work together to fearlessly uncover new possibilities Reporting to the Head of Global Planning, Ultragenyx is seeking a highly motivated Associate Director, Clinical Supply Gene Therapy with expertise in end-to-end pharmaceutical clinical supply strategies and operations. In this position you will be responsible for...

  • Registered Nurse

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Novato, United States CareerBuilder Full time

    Registered Nurse (RN) Staff Nurse is a licensed professional nurse directly under the supervision of the Director of Nursing Services that provides care and services to residents in a long-term care setting. Registered Nurse (RN) Staff Nurse Qualifications: Graduate of an accredited RN school of nursing. Current nursing license, in good standing with the...