Requisition ID: PRO019749
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Small Scale Organic (SSO) Pilot Plant is a GMP manufacturing facility in the Process Research and Development (PR&D) organization. The plant's mission is to support process development and Active Pharmaceutical Ingredient (API) manufacturing for Merck small molecule development programs.
The SSO Plant Engineer will provide hands on assistance for daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements to meet SSO objectives and customer requirements. The position is responsible for implementing actions to meet S&E and GMP requirements. This position is also responsible for ensuring facility readiness for API processing and shares accountability for the building performance. Ultimately, this position is expected to work cooperatively with the SSO leadership team and SSO partners to drive overall success and performance of the building.
• Under the scientific direction of a team lead, the plant engineer will participate in the planning and execution of equipment setups and batch processing at a pilot scale, capture process knowledge, and troubleshoot equipment with the aim of supplying API for clinical use and drug product development, advancing process development, and aiding technology development. This will involve handling of a variety of reagents, solvents and active pharmaceutical ingredients during "wet chemistry" operations (performing chemical reactions, crystallizations, distillations, etc.) as well as dry powder processing (e.g., dry milling).
• Ensure processes are run within the capability constraints of the facility.
• Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and consumable inventory.
• Provide input for incident root cause analysis, reporting, and action items.
• Facilitate and drive building improvement projects and corrective/preventative action closures.
• Provide input on process setups.
• Provide regular feedback (both constructive and positive) to peers to promote a continuous improvement mindset.
• Collaborate with all building staff to share and align on best practices.
• Actively investigate problem statements and SORs to promote fast and efficient closure.
• Understand High Risk Work.
• Identify opportunities to improve building efficiency, compliance, and safety.
• Author lessons learnt and summary reports to capture knowledge.
Education Minimum Requirement: Bachelor's degree in Chemistry, Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline required
Required Experience and Skills:
• Understanding of/Experience with process scale-up of chemical processes, moving from the laboratory to the pilot scale.
• Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams.
• A strong mechanical aptitude.
• Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software.
Preferred Experience and Skills:
• Lean Six Sigma Training / Certification.
• Operations experience.
• Familiarity with the administration of Current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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Job: Process Engineering
Employee Status: Regular
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: Yes; Solvents and reagents
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark