PAT Specialist Job

Date: Jul 12, 2019

Location: Cramlington, ENG, GB

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Requisition ID: PRO019886

MSD is a global health care leader with a diversified
portfolio of prescription medicines, vaccines and animal health products. The
difference between potential and achievement lies in the spark that fuels
innovation and inventiveness; this is the space where MSD has codified its
125-year legacy. MSD’s success is backed by ethical integrity, forward
momentum, and an inspiring mission to achieve new milestones in global
healthcare.



 


As a PAT Specialist, you will act as a subject matter expert
for the site, providing PAT (Process Analytical Technology) support for all
applicable drug products manufactured or tested at MSD Cramlington, UK.  You will work within the technical team at
the Cramligton site and be aligned with the specialist global PAT group in the
United States.  Reporting through the
site PAT group within the Global Technical Operations organization, you will
work with Operations, Quality and Technical specialists to generate, validate
and steward use of digital process data, control methodologies and PAT
measurement models. You will be engaged in process development, investigations
and problem solving as well as facilitation of the Technology Transfer &
Validation of processes and products for new markets. You will be responsible
for enhancing the use of PAT tools and techniques by colleagues. You will also
support successful operation of new Continuous Manufacturing facilities at the
Cramlington site, with considerable scope to pioneer the use of this technology
for advanced process control within the company.



 


The scope of the contributions includes development and
implementation of advanced real-time technologies to support development of new
products as well as methods for process control applications in manufacturing
to ultimately help meet MSD’s World Class Supply objectives of highest quality,
lowest cost, and shortest lead time. The role also providing expertise for
regional support at other sites within the Global Technical Operations
organization.



 


Responsibilities for PAT supports of Batch and Continuous
Manufacturing processes



  • Support production and release of significant
    volume products where PAT methodologies, such as NIR spectroscopy, are used for
    in-process testing and real time release

  • Contribute to risk assessments as well as
    planning and evaluation of Design of Experiment (DoE’s.), process data
    analysis, statistical modelling, multivariate modelling and analysis, online
    (MDVA).

  • Act as Site PAT specialist to enhancing PAT
    capability and application to deliver effective, efficient supply of products

  • Train others on the use of PAT tools (such as
    spectroscopy) and techniques (such as chemometric model development).

  • Maintain and develop the PAT data and models
    applicable to products to ensure reliable, compliant supply

  • Provide PAT support for non-routine and complex
    investigations across all Product Value Streams.

  • Enable 
    process improvement initiatives in alignment with other technical teams.

  • Provide support for writing and updating SOP and
    JIs related to PAT methods



 


Responsibilities for PAT Technology Transfer &
Validation in support of products for new markets.



  • Execute PAT projects independently or in
    cross-functional teams.

  • Liaise with Operations, Technical Operations and
    Engineering to support business case development and robust PAT implementation
    on plant for both new and existing equipment.



 


Responsibilities for PAT implementation in the emerging
Continuous Manufacturing platform



  • Support the design, installation, qualification
    and operations of  new plant and
    equipment  in Cramlington, specifically
    with the PAT applications and equipment and develop and maintain the PAT
    strategic direction

  • Enhance the application of PAT technologies
    within the business, using the contrinuous manuafacturing platform to pioneer
    Advanced Process Control methdologies.

  • Identify the needs for process analytical
    technology innovation based on collaboration and interactions with business, research,
    and manufacturing teams.

  • Collaborates with internal groups and external
    partners and equipment suppliers.

  • Assist in technology screening and conduct
    feasibility studies, collaborating with internal and external partners or
    academic institutions as needed



 


Responsibilities in support of MSD operations in other
facilities as required.



  • Collaborate with colleagues regionally and
    worldwide on in-line production support, tech transfers and capital projects.

  • Liase regularly with global PAT group to ensure
    alignment with company strategy and expertise, and best practices



 


 


 



Qualifications

  • Master’s or PhD degree in Sciences, Analytical
    Chemistry, or Chemical Engineering required with applicable experience.

  • OR
  • Bachelors degree plus 4 years relevant working
    knowledge on PAT, chemometrics and spectroscopic methodologies.

  • Must be highly flexible and possesses relevant
    experience in working in an international and multidisciplinary environment and
    able to support the needs of reliable production and supply      

  • Working knowledge of current Good Manufacturing
    Practices (cGMP) preferred and pharmaceutical production and development
    technologies is highly desirable

  • Applicant must have excellent written and oral communication
    skills and will be expected to continually draw upon his/her ability to think
    independently, to solve problems, and to apply innovative scientific
    approaches.

  • Positive approach to team working and continuous
    improvement.

  • Understanding of equipment installation,
    qualification, and operating principles.

  • Individual time management, able to effectively
    multitask and exhibit project management skills.



 


Your role at MSD is integral to helping the world meet new
breakthroughs that affect generations to come, and we’re counting on your
skills and inventiveness to help make meaningful contributions to global
medical advancement. At MSD, we’re inventing for life.



 


 


MSD is not accepting unsolicited assistance from search
firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any
employee at MSD via email, the Internet or in any form and/or method without a
valid written search agreement in place for this position will be deemed the
sole property of MSD.  No fee will be
paid in the event the candidate is hired by MSD as a result of the referral or
through other means.






Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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