Process Validation Engineer

hace 6 meses

Madrid, España Oxford Global Resources A tiempo completo

**Process Validation Engineer**:

- Location:
Alcalá de Henares, Spain
- Contact:
Susagna Sastre Magem
- Job type:
Contract
- Industry:
Pharmaceutical, Life Sciences, Biotechnology

**Process Validation Engineer**

**Languages**:English and Spanish

**Onsite / Remote**:onsite required Madrid

**Start**:ASAP

**Location**:Madrid

**PROJECT DESCRIPTION**

Compliant execution of process, packaging and cleaning validation activities according to the Validation Master Plan for our client in Madrid site. Including building validation strategies, writing and execution of the protocol and compilation of the final report.
Executes MS&T process projects and formulation activities providing technical support for projects associated with the currently marketed OTC products. Support the introduction and/or transfer of products into the plant.
Work collaboratively with our client in Madrid site cross-functional team for planning and execution of the validation activities. Personally oversee validation activities and support and train operators in the correct execution of the validation protocols.
Support Manufacturing process problem resolution, by involvement in investigations and problem solving/root cause analysis forums. Review the impact assessments, propose corrective actions, and provide technical justifications when required.

**SKILLS/** **QUALIFICATIONS** **NEEDED**

7 + years of experience in validation or drug product manufacturing or related area within the pharmaceutical industry and technical knowledge is essential.

**Desired Qualifications**:

- Broad knowledge of pharmaceutical manufacturing processes and packaging equipment/processes
- Broad knowledge and skills of cleaning validation, cleaning processes and cleaning assessments
- Strong oral and written communication skills in English
- Well organized, committed, flexible, and enjoy working on the shop floor.
- Able to work shifts when required
- Capacity to influence others without direct line authority.
- Strong leadership skills and team spirit to collaborate with varied people at different levels
- Capacity to work in autonomy while handling multiple priorities.
- Good verbal and written English
- Experience with statistical computer packages

**RESPONSIBILITIES**

Cleaning validation:

- Define the Cleaning validation strategy for projects where applicable.
- Perform cleaning validation for the introduction of new products to the site or changes to the current product which may potentially impact the cleaning validation status of manufacturing or packaging equipment.
- Establish cleaning assessments for the cleaning process potentially impacted by change.
- Develop the necessary documentation for the realization of the validation runs e.g. cleaning protocols & reports, new recipes and the training of these to production staff involved in the validation activity, if applicable.
- Coordinate with production to ensure that cleaning validation activity is performed.
- Coordinate with QC for the analysis of samples and reporting of results.
- In the event of non-compliance during cleaning validation, investigate, participate in impact assessment, and propose corrective actions.
- Update cleaning instructions as appropriate.

Process validation:

- Define validation strategy for the assigned projects.
- Process validation (manufacturing, storage of bulk & packaging) either for the introduction of new products/new materials to the site or changes to the current product e.g. a change of API or excipient/change of primary packaging.
- Creation of protocols and reports to support process validation e.g. characterization and validation activities.
- Collaborate with Production and Quality in the creation of batch documentation required to support process validation e.g. batch manufacturing records.
- Train the relevant production personnel in support of validation activities.
- Follow the production of lots of validation and realize samples.
- Manufacturing process problem resolution and support investigations into deviations during validation activities or routine production, assess and propose corrective actions.
- Follow rules of conformity defined by the guide of the good manufacturing practices of the pharmaceutical industry (cGMP) as well as the guidelines and procedures (Quality and Compliance) defined on the plant.
- Ensuring adequate documentation is available to support registration of projects.
- Assuring appropriate risk management within the validation strategy
- Assuring appropriate communication to stakeholders
- Audit readiness

  • Process Validation Engineer New

    hace 6 meses

    Madrid, España Oxford Global Resources A tiempo completo

    Location: Alcalá de Henares, Spain - Contact: Susagna Sastre Magem - Job type: Contract - Industry: Pharmaceutical, Life Sciences, Biotechnology **Process Validation Engineer** **Languages**:English and Spanish **Onsite / Remote**:onsite required Madrid **Start**:ASAP **Location**:Madrid **PROJECT DESCRIPTION** Compliant execution of process,...

  • Senior Process Engineer

    hace 4 meses

    Madrid, España The Chemical Engineer A tiempo completo

    .JOB DESCRIPTIONWood is currently looking for a Senior Process Engineer to participate in our Basic design projects for international clients across the energy transition markets, especially in relation to the hydrogen value chain, as well as petrochemicals, and refining sectors.We are looking for an experienced engineer, with a broad range of process design...

  • Senior Process Engineer

    hace 2 semanas

    Madrid, España The Chemical Engineer A tiempo completo

    .JOB DESCRIPTION Wood is currently looking for a Senior Process Engineer to participate in our Basic design projects for international clients across the energy transition markets, especially in relation to the hydrogen value chain, as well as petrochemicals and refining sectors. We are looking for an experienced engineer, with a broad range of process...

  • System Validation Engineer

    hace 1 mes

    Madrid, Madrid, España Amazon A tiempo completo

    Job SummaryAWS Utility Computing (UC) provides innovative services that set the industry apart. As a member of the UC organization, you'll support the development and management of Compute, Database, Storage, Internet of Things (IoT), Platform, and Productivity Apps services in AWS. Within AWS UC, Amazon Dedicated Cloud (ADC) roles engage with customers who...

  • Senior Process Engineer

    hace 2 días

    Madrid, España The Chemical Engineer A tiempo completo

    JOB DESCRIPTIONWood is currently looking for a Senior Process Engineer to participate in our Basic design projects for international clients across the energy transition markets, especially in relation to the hydrogen value chain, as well as petrochemicals and refining sectors.We are looking for an experienced engineer, with a broad range of process design...

  • Senior Process Engineer

    hace 3 semanas

    Madrid, España The Chemical Engineer A tiempo completo

    JOB DESCRIPTION Wood is currently looking for a Senior Process Engineer to participate in our Basic design projects for international clients across the energy transition markets, especially in relation to the hydrogen value chain, as well as petrochemicals and refining sectors. We are looking for an experienced engineer, with a broad range of process design...

  • Senior Process Engineer

    hace 3 semanas

    Madrid, España The Chemical Engineer A tiempo completo

    JOB DESCRIPTIONWood is currently looking for a Senior Process Engineer to participate in our Basic design projects for international clients across the energy transition markets, especially in relation to the hydrogen value chain, as well as petrochemicals and refining sectors.We are looking for an experienced engineer, with a broad range of process design...

  • Senior Process Engineer

    hace 4 meses

    Madrid, España The Chemical Engineer A tiempo completo

    JOB DESCRIPTIONWood is currently looking for a Senior Process Engineer to participate in our Basic design projects for international clients across the energy transition markets, especially in relation to the hydrogen value chain, as well as petrochemicals, and refining sectors.We are looking for an experienced engineer, with a broad range of process design...

  • Power Electronics Validation Engineer

    hace 1 mes

    Madrid, España Https:Www.Energyjobline.ComSitemap.Xml A tiempo completo

    .It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa we make real what matters, join our global team. Siemens Gamesa is part of Siemens Energy, a global leader in energy technology with a rich legacy of innovation spanning over 150 years. Together, we are committed...

  • Power Electronics Validation Engineer

    hace 1 semana

    Madrid, España Siemens Gamesa A tiempo completo

    .It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa, we make real what matters. Join our global team.Siemens Gamesa is part of Siemens Energy, a global leader in energy technology with a rich legacy of innovation spanning over 150 years. Together, we are committed...

  • System Validation Engineer

    hace 1 mes

    Madrid, España Amazon A tiempo completo

    AWS Utility Computing (UC) provides product innovations — from foundational services such as Amazon's Simple Storage Service (S3) and Amazon Elastic Compute Cloud (EC2), to consistently released new product innovations that continue to set AWS's services and features apart in the industry.As a member of the UC organization, you'll support the development...

  • System Validation Engineer

    hace 1 mes

    Madrid, España Amazon A tiempo completo

    AWS Utility Computing (UC) provides product innovations — from foundational services such as Amazon's Simple Storage Service (S3) and Amazon Elastic Compute Cloud (EC2), to consistently released new product innovations that continue to set AWS's services and features apart in the industry. As a member of the UC organization, you'll support the development...

  • System Validation Engineer

    hace 1 mes

    Madrid, España Amazon A tiempo completo

    AWS Utility Computing (UC) provides product innovations — from foundational services such as Amazon's Simple Storage Service (S3) and Amazon Elastic Compute Cloud (EC2), to consistently released new product innovations that continue to set AWS's services and features apart in the industry. As a member of the UC organization, you'll support the development...

  • System Validation Engineer

    hace 1 mes

    Madrid, España Amazon A tiempo completo

    AWS Utility Computing (UC) provides product innovations — from foundational services such as Amazon's Simple Storage Service (S3) and Amazon Elastic Compute Cloud (EC2), to consistently released new product innovations that continue to set AWS's services and features apart in the industry. As a member of the UC organization, you'll support the development...

  • Process Engineer

    hace 6 meses

    Madrid, España Pharmeng Technology Inc A tiempo completo

    **PharmEng Technology** is a global ISO certified Pharmaceutical Compliance Consulting Firm with projects around the world providing quality services to the manufacturers of pharmaceutical and health care products for over 25 years. Our 300+ global consultants have expertise in Commissioning & Qualification, Validation, Quality Systems, Engineering, Medical...

  • Power Electronics Validation Engineer

    hace 5 meses

    Madrid, España Siemens Gamesa A tiempo completo

    .About Siemens Gamesa:It takes the brightest minds to be a technology leader. It takes imagination to create green energy for the generations to come. At Siemens Gamesa we make real what matters, join our global team. Siemens Gamesa is part of Siemens Energy, a global leader in energy technology with a rich legacy of innovation spanning over 150 years....

  • Verification and Validation Engineer

    hace 1 mes

    Madrid, Madrid, España Clue A tiempo completo

    About the RoleAt Clue, we are seeking a highly skilled Verification and Validation Engineer to join our team. As a key member of our engineering group, you will be responsible for ensuring the quality and reliability of our safety-critical software systems.ResponsibilitiesDevelop and maintain software verification plans in accordance with DO-178C.Define...

  • Quality Process Engineer

    hace 2 semanas

    Madrid, Madrid, España Bd A tiempo completo

    About the RoleAs a Process Engineer at Bd, you will be accountable for leading technical support in the specification, purchase, installation, and continuous improvement of production processes. This involves coordinating projects, including new products, capacity expansion, and process development on pilot and industrial tools and equipment.Main...

  • Flight Software Engineer for Verification and Validation

    hace 1 mes

    Madrid, Madrid, España Deimos Space A tiempo completo

    Deimos Space is seeking a skilled Flight Software Engineer for Verification and Validation to join its Avionics Business Unit. The selected candidate will be part of an international team of highly qualified engineers and will have the opportunity to work on exciting space missions, such as Earth Observation and Space Debris Removal.The successful candidate...

  • Test and Validation Engineer

    hace 6 días

    Madrid, Madrid, España Alstom A tiempo completo

    Unlock Your Potential as a Test and Validation EngineerAt Alstom, we're revolutionizing the transportation industry by pushing the boundaries of innovation. As a leading provider of rail solutions, we're committed to making travel faster, safer, and more efficient.About the Role:We're seeking an experienced Test and Validation Engineer to join our team in...