Validation Engineer

  • location: New Haven, CT
  • type: Contract
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job description

Validation Engineer

job summary:




The primary responsibility of this position will be to complete process validation and technology transfer activities of drug substance biological manufacturing processes to internal or external manufacturing sites. This role will constitute a combination of 75% process validation and 25% technology transfer activities for programs that are already in progress. The qualified candidate is generally considered to have experience/ knowledge as a subject matter expert (SME) and will support the clients team on process validation and tech transfer activities for all manufacturing projects. This will be accomplished in collaboration with Process Development, Technology Transfer / Technical Services, Validation, Supply Chain, Quality, Regulatory, and other involved departments. The qualified candidate will contribute as an SME within internal project teams to identify and complete necessary tasks. Responsibilities include but are not limited to review of master plans, protocols, final PV reports, to complete closure for regulatory filing, review of engineering reports as they pertain to process transfer and BLA filing, review CTD sections and source documents for regulatory filings and scheduling to meet necessary timelines.







  • Responsible to review process validation protocols and initial/final reports. This would include but not limited to the following: mock runs, resin storage, membrane storage, uniformity testing, mixing studies, review of Process Performance Qualification protocol/reports (PPQ: USP and DSP) as well as others as defined by the process validation master plan.
  • Responsible for review of project CTD section(s) for regulatory filing as defined within the project schedule. This may require authoring as well as provide technical review of a CTD section based on executed manufacturing and process validation campaign at CMO.
  • Responsible for preparing internal technical documentation to respond to "Information Requests" from auditing agency's post submission(s) as necessary per the project team.
  • Potential support in Mock audits in prep for Pre Approval Inspection (PAI) as well as within a PAI itself.
  • Responsible to provide technical guidance and support for both internal/external transfers of clinical or commercial products in to large scale (10,000 - 20,000 L bioreactor scale) GMP manufacturing facilities.
  • Establish and coordinate continuous communication with Quality Assurance, Quality Control, Process Development and Analytical Sciences and Supply Chain teams to ensure continued efficient tech transfer of Alexion's commercial and clinical drug substance manufacturing activities.
  • Ensure that day to day progress on process validation and or technical transfer tasks is communicated and maintained to meet overall project timelines
  • Partner with internal QA and external facilities to provide technical support for troubleshooting and general technical oversight of processes at external manufacturing facilities and ensure timely closure and approval of deviations, OOS, CAPAs and Change Controls
  • Global role requiring domestic/international travel (~10%). Capability to travel internationally is likely.






Skills:



  • 8-11+ years in support of Process Validation required and Tech Transfer experience preferred. Understanding of upstream cell culture and downstream purification operations as well as experience with process validation and technical transfer projects with familiarity of various biopharmaceutical unit operations.
  • Experience in collaborating with contract manufacturing companies and interfacing with their internal project teams
  • Experience preferred in BLA/MAA/CMC documentation as well as direct audit and filing experience
  • Basic understanding of CGMP requirements for clinical and commercial biopharmaceutical manufacturing.
  • Excellent structured problem solving, planning and organization skills. Proven ability to work under pressure.
  • Must be able to analyze data using basic statistical methods.
  • Strong interpersonal skills and ability to identify and collaborate with key stakeholders across functions
  • Must be flexible and able to manage multiple tasks effectively while prioritizing appropriately
  • Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners
  • Ability to influence others without direct authority and communicate with all levels of the organization
  • Strong understanding of bio-pharmaceutical industry (regulatory environment) and supply chain process




 
location: New Haven, Connecticut
job type: Contract
work hours: 9am to 5pm
education: Bachelors
 
responsibilities:
The primary responsibility of this position will be to complete process validation and technology transfer activities of drug substance biological manufacturing processes to internal or external manufacturing sites. This role will constitute a combination of 75% process validation and 25% technology transfer activities for programs that are already in progress. The qualified candidate is generally considered to have experience/ knowledge as a subject matter expert (SME) and will support the clients team on process validation and tech transfer activities for all manufacturing projects. This will be accomplished in collaboration with Process Development, Technology Transfer / Technical Services, Validation, Supply Chain, Quality, Regulatory, and other involved departments. The qualified candidate will contribute as an SME within internal project teams to identify and complete necessary tasks. Responsibilities include but are not limited to review of master plans, protocols, final PV reports, to complete closure for regulatory filing, review of engineering reports as they pertain to process transfer and BLA filing, review CTD sections and source documents for regulatory filings and scheduling to meet necessary timelines.

 
qualifications:
  • Responsible to review process validation protocols and initial/final reports. This would include but not limited to the following: mock runs, resin storage, membrane storage, uniformity testing, mixing studies, review of Process Performance Qualification protocol/reports (PPQ: USP and DSP) as well as others as defined by the process validation master plan.
  • Responsible for review of project CTD section(s) for regulatory filing as defined within the project schedule. This may require authoring as well as provide technical review of a CTD section based on executed manufacturing and process validation campaign at CMO.
  • Responsible for preparing internal technical documentation to respond to "Information Requests" from auditing agency's post submission(s) as necessary per the project team.
  • Potential support in Mock audits in prep for Pre Approval Inspection (PAI) as well as within a PAI itself.
  • Responsible to provide technical guidance and support for both internal/external transfers of clinical or commercial products in to large scale (10,000 - 20,000 L bioreactor scale) GMP manufacturing facilities.
  • Establish and coordinate continuous communication with Quality Assurance, Quality Control, Process Development and Analytical Sciences and Supply Chain teams to ensure continued efficient tech transfer of Alexion's commercial and clinical drug substance manufacturing activities.
  • Ensure that day to day progress on process validation and or technical transfer tasks is communicated and maintained to meet overall project timelines
  • Partner with internal QA and external facilities to provide technical support for troubleshooting and general technical oversight of processes at external manufacturing facilities and ensure timely closure and approval of deviations, OOS, CAPAs and Change Controls
  • Global role requiring domestic/international travel (~10%). Capability to travel internationally is likely.
 
skills:
  • 8-11+ years in support of Process Validation required and Tech Transfer experience preferred. Understanding of upstream cell culture and downstream purification operations as well as experience with process validation and technical transfer projects with familiarity of various biopharmaceutical unit operations.
  • Experience in collaborating with contract manufacturing companies and interfacing with their internal project teams
  • Experience preferred in BLA/MAA/CMC documentation as well as direct audit and filing experience
  • Basic understanding of CGMP requirements for clinical and commercial biopharmaceutical manufacturing.
  • Excellent structured problem solving, planning and organization skills. Proven ability to work under pressure.
  • Must be able to analyze data using basic statistical methods.
  • Strong interpersonal skills and ability to identify and collaborate with key stakeholders across functions
  • Must be flexible and able to manage multiple tasks effectively while prioritizing appropriately
  • Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners
  • Ability to influence others without direct authority and communicate with all levels of the organization
  • Strong understanding of bio-pharmaceutical industry (regulatory environment) and supply chain process

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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