Job Description
A fantastic opportunity has arisen for a highly skilled and energetic Sr.
Specialist Process Engineering to join the team at our Biologics INnovation Xceleration (BioNX) facility in Dunboyne.
Purpose of Role: The Biologics INnovation Xceleration (BioNX) facility at Dunboyne will be a premier, state-of-the-art facility that enables and advances our best work.
By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions.
The BioNX Facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.
As a member of the Manufacturing Technologies and Engineering group, you will be responsible for the evaluation and implementation of novel equipment, innovative processes, and the implementation of next-generation technologies to keep our company at the forefront of innovation in the development and manufacturing of biologics.
What you will do: Participate in the planning, coordination, and implementation of next-generation technologies being implemented in Batch and Continuous Manufacturing by leading and supporting the:Transfer of platform technologies from the earlier pipeline facilities, and bringing to GMP status locally.Transfer of platform technologies to future commercial facilities.Partnering within a cross-functional team to implement new technologies/software/instruments that can simplify and reduce effort around manufacturing and administrative processes, sharing with network counterparts.Supporting the development of GMP Documentation such as: Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and SOPs.Supporting troubleshooting and acting as SME for manufacturing technology.Aggregate process-related knowledge and centralize for knowledge management.
Maintain GMP status of responsible equipment and areas by conducting routine monitoring, calibration, maintenance, certifications as needed.Support the area's implementation of process changes and root cause investigation of deviations.Support Weekend or On-Call duty on select time frames to support manufacturing during new technology introduction.Own life cycle development and qualification from initiation through implementation of methods/recipes for automated equipment, integrating into the overall site DeltaV System.Active member of a cross-functional team managing both process and automation aspects of responsible unit operations.Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environment goals.What skills you will need: Bachelor's degree in Biology, Automation, Medical Device Technologies, or Engineering.6+ years of experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).Familiarity with Unit Operations for biologics manufacturing.Competent in analyzing complex situations and show practical problem-solving capabilities.Equipment qualification/validation experience.Deviation management and change control systems.Verbal or spoken communication skills in English.Ability to work independently and within a cross-functional team.As a company, we are committed to 'Inventing for Life' in all that we do.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
So, if you are ready to: Invent solutions to meet unmet healthcare needs, impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position-specific.
Please, no phone calls or emails.
Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/30/2025
*A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R329707
#J-18808-Ljbffr