Specialist, Manufacturing Engineer

Merck•Rahway, NJ

1d•$79,200 - $124,700•Onsite

About The Position

Pharmaceutical Operations and Clinical Supply is seeking a highly motivated individual for a Manufacturing Engineering position to support specialty dosage forms and oral solid dosage GMP development activities. This role is primarily responsible for continuous improvement of processing activities including the setup, operation, and cleaning of equipment for clinical batch processing and equipment troubleshooting within our clinical supply Formulation Laboratory and Experimentation (FLEx) Early Development Center (EDC). The successful candidate will become an owner and trainer of key pieces of equipment, focusing on specialty setups (e.g. potent processing isolators, dry powder inhalers, autoencapsulation). They will lead the team through room setup, equipment assembly and disassembly, along with managing and completing GMP documentation. They will also build a strong team dynamic through continual sharing of knowledge and identification of improvements. They will work closely with peer specialists, formulation scientists, facility engineers and automation engineers to fix equipment/system issues and solve root causes. By taking initiative and owning improvement projects to completion, the candidate will help the team progress on our continuous improvement journey.

Requirements

Bachelor’s in Engineering or Pharmaceutical Sciences and two years of experience in a related field
Independent planning, scheduling, and time management skills.
Ability to troubleshoot and resolve issues utilizing digital skill sets
Demonstrated mechanical aptitude

Nice To Haves

Experience in GMP pharmaceutical plant operations
Experience with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)
Working knowledge of regulatory requirements within GMP manufacturing facilities, and demonstrated focus on details and proper execution of batch manufacturing.
Experience with some of the following: Oral Solid Dosage, Tablet Compression, Encapsulation, Spray Drying, Film Coating, Dry Powder Inhalers, Drug Product Device assembly lines, Isolators, Containment technology
Experience working with Lean / Six Sigma and continuous improvement projects
Experience with: PI Visions, Equipment HMI use, SAP, Microsoft Office (Word, Excel and Outlook).
Experience working with safety team on industrial hygiene monitoring, investigations, improvements, and focus on safety working culture.

Responsibilities

Lead improvement activities on specialty equipment trains in the oral solid dosage facility
Coordinate processing and troubleshooting on designated equipment trains
Define and improve standard work, SOPs, BTD, and overall production flow
Support standard Non-Sterile processing as time allows.
Ensure adherence to Good Manufacturing Practices, draft and review process steps, SOPs, quality procedures, safety, and environmental standards.
Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.
Develop experience to become an equipment expert and share knowledge by teaching others.
Troubleshoot equipment problems.
Execution of GMP batch documentation in accordance with local and global operating procedures.
Provide support to engineering and formulations staff on Good Manufacturing Practices, equipment operations, facility maintenance and batch specific items.
Identify and document deviations and atypical events.
Lead investigations and document as required.
Support investigations and the implementation of corrective/preventive actions.
Support external and internal audits, tours and inspections.
Author or assist with the development of SOPs.
Complete training and ensure it is up to date.
Interface with engineering and maintenance personnel for equipment repair issues, ensuring proper procedure and change control is followed. Ensure downtime minimization.
Lead improvement initiatives.