Job Description

A fantastic opportunity has arisen for a Specialist Engineering. This role reports to OSD Commercialisation Technical Lead or Spray Dryer Commercialisation & IPT Technical Lead. 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 conjunction with R&D and Roller Compaction Facility and the Spray Drying Facility. The Development Engineer provides technical assistance to the resolution of IPT processing issues when requested. Also provides support for new product demonstrations, and the technology transfer to the Supply organization, and/ or to external plants.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Provides scientific and technical support to the IPT for multiple processes and technology. This support involves evaluation of raw materials including new suppliers, development of process fits, participation in campaign preparation and follow-ups. It also involves safety and HAZOP reviews, process monitoring and time cycle analysis, atypical investigations and resolutions including trending and prevention, defining cleaning processes for new production processes and review of the cleaning procedures/ documentation.
• Has a mastery of the scientific/ technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/ technical issues.
• Operates effectively as leader of a project, or a key member of multiple smaller teams, and uses planning which identifies needs, priorities, risks, responsibility and accountability.
• Continuously develops skills in and routinely applies appropriate tools to measure and enhance functional and team performance.
• Uses feedback to ensure that customer /stakeholder needs are the cornerstone of his/ her decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems.
• Utilizes scientific and functional expertise inside and outside of core specialty to develop value added solutions to customer needs.
• Continually improves communication systems and practices within and across teams/ units/ functions.
• Proactively reviews own performance and progress and seeks feedback from manager/ peers/ customers to close gaps.
• Provides frank, timely and tactful communication and feedback to others.
• Performs CDS engineering operations in compliance with cGMP, Environmental, Labour, Industrial Health and Safety regulations.
• Carries out all CDS managed processes or operations in conformance with site divisional and corporate quality standards and that all deviations from standards are thoroughly investigated and corrected. As part of the Quality Management System the incumbent is the Sub-System Owner for various QMS sub-systems i.e. Cleaning/ Housekeeping/ Maintenance, PM/ Calibration and Facilities/ Equipment Design.
• Informs the CDS Pharm Tech Head about situations and/ or trends that are affecting CDS performance (atypical, accidents, events, audit findings, regulatory issues, among others) and request support as needed.
• Accountable for keeping up to date with ongoing training and development.

What skills you will need:

In order to excel in this role, you will more than likely have:

• BSc or higher in Chemistry, Chemical Engineering or Natural Sciences
• Process chemistry, formulation technology and engineering principles
• Process, equipment & cleaning validation
• cGMP’s
• Knowledge of production operations
• Batch sheets
• Deviation System
• Process, equipment & cleaning validation
• Regulatory requirements
• CDS, ADC and Quality policies and procedures
• IPT policies & procedures
• HR policies and procedures
• Safety policies and procedures
• Environmental policies and procedures
• 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 judgements on limited data
• Manage a diverse range of projects in a changing environment and to respond with flexibility
• Think and act strategically
• Trains and develops employees
• Treats partners and team members with dignity and respect
• Complete assignments and make decisions in a timely manner
• Actions reflect a high degree of integrity and ethics
• Focus on customers and patients
• Act with courage and candor
• Foster collaboration
• Demonstrates the principles of inclusion
• Written and verbal presentation skills and communication skills
• Team work skills and ability to work across boundaries
• Skills in leading work teams
• Performance management
• Project management skills
• Skills in leading work teams
• Problem solving
• Financial management skills
• Customer service skills
• Interpersonal skills
• Time management

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

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:

05/21/2025

*A job posting is effective until 11:59:59PM 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.