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Associate DP MSAT Engineer

Employer
Regeneron
Location
Dublin, Ireland
Salary
Competitive
Start date
7 Apr 2024
Closing date
7 May 2024

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Discipline
Manufacturing
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

In this role you will support equipment selection, CMO selection strategy, management of equipment qualification and process validation activities. You will be hands-on solving issues during technology transfer and cGMP start-up and take ownership for providing floor support during operations of off-site manufacturing. This role is responsible for reviewing process data to ensure operational consistency after the processes are successfully transferred and also providing investigation support.

As a DP MSAT Engineer a typical day might include, but is not limited to, the following:
  • Providing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution
  • Act as the technical lead, with the support of cross-functional teams, for technology transfer
  • Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc.
  • Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.)
  • Assisting with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations
  • Trending process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations
  • Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities
  • Supports development of sampling plans for GMP batches related to lot release, stability and characterization
  • Works with Manufacturing to ensure robust procedures are utilized for operation of equipment
  • Partners with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery
  • Travels to contract manufacturers or business partners, as required, up to 25-50%

This role might be for you if you:
  • Demonstrate technical knowledge in drug product manufacturing, product development and validation
  • Possess knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)
  • Have strong project management and negotiation skills
  • Demonstrate excellent interpersonal, and communication skills
  • Have strong problem-solving abilities

To be considered for this opportunity you should have a BS/BA in engineering or equivalent combination of education and experience.

Engineer: Requires BS/BA in engineering and 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience.

Senior Engineer: Requires BS/BA in engineering and 5 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience.

#IREADV #JOBSIEPR #LI-Onsite

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

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