Associate Engineering Specialist

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) 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, OSD/Spray drying characterization, and Design space development.
• Clinical and formal stability batch manufacture,
• Leading and participating in cross functional teams to carry out Quality Risk Assessments, Quality Investigations, and Safety Assessments.
• Process validation.
• 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.
• Support commercial supply activities such as
  • Process and cleaning recipe and documentation preparations.
  • Technical support to production and cleaning campaigns.
  • Trouble shooting, investigations and documenting process issues and deviations.
  • Identifying and implementing process improvement and optimization opportunities.
• 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 1- 2 years relevant experience in Oral Solid Dosage or Spray Drying.
• Strong oral communication skills
• Proficiency in technical writing.
• Work independently and deliver work task on time.
• Bachelors or postgraduate degree in Chemical or Process Engineering or a Science related discipline.

  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) 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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID: R290664