Process and Technical Engineering Lead Dunboyne
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Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Job Description
A compelling opportunity has arisen for a Process and Technical Engineering Lead to provide technical leadership across a diverse biologics portfolio spanning multiproduct clinical and commercial manufacturing facilities. Reporting to the Global Head of Biologics Technical Operations this role is accountable for driving technical rigor and excellence from a facilityfit and process engineering perspective enabling rightfirsttime execution as processes are transferred across the internal and external manufacturing network while also supporting ongoing commercial manufacture.
The role combines strategic oversight with handson technical leadership across biologics drug substance (DS) manufacturing with responsibility across multiple facilities and suites. A strong understanding of the interplay between automation process equipment and facility design is central to success in this position.
Key Responsibilities
Technical Leadership & Facility Fit
- Provide endtoend technical leadership for facilityfit assessments for both inline and New Product Introduction (NPI) programs ensuring robust evaluation of processequipmentfacility interfaces.
- Lead the identification prioritization and resolution of engineering issues arising during facilityfit activities and execution readiness including support to batchrelated activities as required.
- Deliver strong technical oversight to ensure technical excellence and rightfirsttime execution during process transfers into the internal and external manufacturing network.
Process & Equipment Expertise
- Act as a subject matter expert (SME) in biologics process equipment maintaining deep knowledge of equipment capabilities and limitations across multiple facilities.
- Serve as an SME in the development of digital twin solutions and strategic improvements to support facilityfit activities. Make recommendations for site equipment investments to enable readiness for futurestate molecules and platforms and define KPIs that measure facilityfit success and drive continuous improvement.
- Provide technical input to upstream and downstream platform definitions based on expert understanding of facility capabilities and the interface between manufacturing processes and equipment.
- Collaborate closely with broader Science & Technology (S&T) functions to share expertise build capability and upskill teams on process and equipment understanding.
Team Leadership & Capability Building
- Establish and lead a small focused team of engineers who serve as dedicated experts in processes and process equipment across the manufacturing network.
- Cultivate a culture of technical excellence collaboration and innovation enabling crossfunctional learning and standard methodology sharing.
- Develop mentor and coach engineering team members to build a strong and sustainable talent pipeline.
- Partner with Technical Operations and receivingunit teams to drive New Product Introduction and Technology Transfer activities ensuring a deep understanding of the interconnectivity between operations process and equipment.
Who You Are
You are ready for this role if you have the following:
- B.S. M.S. or Ph.D. in a relevant Engineering or Science discipline.
- A minimum of 9 years experience in biopharmaceutical manufacturing and/or development with a strong emphasis on scientific and technical roles.
- Demonstrated technical excellence with deep understanding of biologics molecules manufacturing processes process equipment and automation.
- Experience in biologics drug substance development technical operations and new product introduction.
- Strong crossdivisional networking and collaboration skills.
- Experience working within technical operations at a manufacturing site.
- Experience with regulatory filings quality notifications investigations and CAPA management.
- Proven leadership with the ability to influence at all organizational levels.
- Strong talentbuilding capabilities with both strategic and detailoriented strengths.
- Solid understanding of product management systems business and financial principles and the ability to manage multiple programs simultaneously.
- A strong sense of urgency motivational leadership style and agility in driving change.
Required Skills:
Biopharmaceuticals Change Management Cross-Functional Leadership Engineering Process Management GMP Operations Manufacturing Systems New Product Introduction (NPI) People Leadership Technical Leadership Technical OperationsPreferred Skills:
Business Strategy Planning Lean Six Sigma (LSS)Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.
As an equal opportunity employer we are proud to be a company that embraces the value of bringing diverse talented and committed people together.
Please dont hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So if you are ready to:
Invent solutions to meet unmet healthcare needs please apply today.
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
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.
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Job Posting End Date:
04/4/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Key Skills
About Company
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicine ... View more
