MSD Engineering Specialist 

Ireland 

170310583

Job Description

This position is for an Engineer in Commercialisation Development and Supply (CDS) group. This group is responsible for process development of Active Pharmaceutical Ingredients (API), Spray Dried Intermediate (SDI) and Oral Solid Drug (OSD) products from Phase IIb through regulatory filings, process validation, and into the first few years of commercial launch. The group is part of the Global Pharmaceutical and Commercialization (GPC) organization and collaborates with colleagues across the globe on developing new products.

What you will do:

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

• Plan, conduct, evaluate and interpret process development studies, including scale-up, Spray drying characterization, and Design space development.
• Plan, provide technical support for execution clinical and primary stability batch manufacture,
• Leading and participating in cross functional teams to carry out Quality Risk Assessments, Quality Investigations, Safety Assessments and Process improvement projects.
• Preparing/Leading/Executing Process and Cleaning Validation activities.
• Supporting commercial supply activities such as
  • Process and cleaning recipe and manufacturing documentation preparations/approvals.
  • Technical support to process and cleaning campaigns.
  • Trouble shooting, leading/ completing investigations, proposing/implementing Corrective and Preventative Actions.
  • Identifying and implementing process improvement and optimization opportunities for both production and cleaning regimes.
• Other responsibilities include data analysis, technology evaluation, and compliance with applicable safety and current good manufacturing practices.

What skills you will need:

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

• Minimum of 3- 5 years relevant experience in Pharma Environment.
• Strong oral communication skills.
• Proficiency in technical writing.
• Problem-solving skills are essential and knowledge of concepts of Quality by Design, including risk-based approaches to development, design of experiments, and process modelling, are desired.
• Ability and willingness to occasionally support shift work depending on the needs of the project or team.
• Ability to learn quickly and work in a fast-paced team environment is desirable.
• Work independently and work as part of the team while meeting all agreed timelines.
• Bachelors or postgraduate degree in Chemical or Process Engineering or a Science related discipline.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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.