Job Description
A fantastic opportunity has arisen for Senior Formulation & Process Engineer (Oral Solid Dose). This position will provide support to the technical area of the formulation facility. Our Formulation R&D facility is the first purpose-built facility supporting oral solid dosage commercialization within the company network. Within this facility, new drug product processes are developed, scaled up, and optimized using cutting-edge manufacturing technology to provide product for clinical trials and commercial supply.
The role reports to the Pharm Ops Technical Lead.
What you will do:
Bring energy, knowledge, innovation, and leadership to carry out the following:
* The Senior Formulation & Process Engineer will have accountability for the provision of technical support to all aspects of production in the Pharm Ops operating area. This will include pre-campaign documentation; recipe management; materials preparations; campaign execution monitoring; troubleshooting; turnaround documentation and technical support; campaign close out and front-line process development and optimization support.
* The Senior Formulation & Process Engineer provides technical assistance to the resolution of IPT processing issues and provides support for new product demonstrations and the technology transfer to the Manufacturing Division Supply organization, and/or to external plants.
* Under general scientific and administrative direction, work as part of the Pharmaceutical CDS team responsible for final pharmaceutical dosage form process development activities to support commercialization of new products, implementing into production, and process improvements.
* In addition, the Senior Formulation & Process Engineer is a key technical leader of the Pharmaceutical CDS group on site. The incumbent will also have strong links to the Core PCT organization.
* The Senior Formulation & Process Engineer will assemble and lead project technical teams responsible for the development of new processes and product launch in this facility.
* Providing strong technical support to production teams including support to daily operations, problem-solving/issue resolution, and driving continuous improvement.
* Leading process and equipment optimization in order to sustain and improve product quality, yields, and throughput.
What skills you will need:
In order to excel in this role, you will more than likely have:
* Bachelor’s or postgraduate degree in Chemical or Process Engineering or a Science-related discipline.
* Minimum of 8 years relevant experience in Oral Solid Dosage drug/process development.
* Detailed understanding of Formulation and Process development activities.
* Detailed understanding of Manufacturing Operations.
* High level of knowledge of documentation and recipe management practices.
* High level of knowledge of Cleaning Validation/Turnaround management.
* High level of knowledge of Safety and Environmental requirements.
* Knowledge of product validation requirements.
* Process and supplier change control and deviation system operations and product quality impact.
* Organization and planning skills.
* Strong Computer skills.
* Excellent communication and technical writing skills.
* Strong problem-solving skills.
* Ability to communicate honestly and continually both in writing and verbally in a concise manner.
* Champion and support innovation and continuous learning.
* Technically evaluate projects, provide appropriate options/solutions, and respond on occasions with rapid judgments on limited data.
* Manage a diverse range of projects in a changing environment and respond with flexibility.
* The ability to work in partnership with personnel in each site department, other company sites, and customers.
* Ability to work as part of a cross-functional team in partnership with people in all departments.
* Written and verbal presentation skills.
* Ability to build and lead a team.
* Performance Management skills.
* Mentoring/people development skills.
* Principle Centered Leadership.
* Interpersonal Skills.
* Proactivity.
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. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
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
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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: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 12/19/2024
*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: R325554
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