Equipment Engineer

SciGen Pte. Ltd.; Hauppauge (NY); Hybrid; USD 74,000 - 90,000; Full time

Job summary

Sciegen Pharmaceuticals Inc. in Hauppauge, NY seeks an Equipment Engineer to analyze requirements and design/update operating and maintenance processes for its advanced manufacturing equipment.

You will monitor internal engineering projects, perform root-cause analysis, develop maintenance solutions, and ensure cGMP, US FDA and OSHA compliance, working with vendors on custom solutions and facilitating equipment qualification activities (IQ/OQ/PQ).

Qualifications

• Bachelor’s degree in mechanical engineering or related field required.
• Minimum 2 years of pharmaceutical industry experience.
• Experience with cGMP, IQ/OQ/PQ protocols.
• Ability to analyze requirements and design/upgrade maintenance processes.

Responsibilities

• Analyze requirements and design/update operating and maintenance processes for equipment.
• Assist in monitoring internal engineering projects and design modifications.
• Develop maintenance solutions and perform root-cause analysis.
• Prepare IQ/OQ/PQ protocols and reports per cGMP requirements.
• Consult with vendors to develop custom equipment solutions and layouts.
• Ensure compliance with US FDA, OSHA guidelines and related standards.

Skills

Equipment design

Root-cause analysis

Vendor collaboration

Process improvement

Education

Bachelor's degree in Mechanical Engineering

Tools

CAD

Job description

Sciegen seeks Equipment Engineer in Hauppauge, NY to analyze requirements and design/update operating and maintenance processes for our technologically advanced and sophisticated manufacturing equipment; assist in monitoring &executing internal engineering projects such as custom design of equipment, machinery and related technology etc.; apply technical expertise to identify areas for improvement and recommend/develop process modifications, design modifications, equipment calibrations etc. to enhance operational efficiencies at the facility; develop maintenance solutions by studying maintenance history and performing root-cause analysis; consult with vendors and prepare custom layout drawings for advanced equipment, sophisticated machinery, site master file layouts, HVAC, piping etc.; prepare IQ, OQ and PQ protocol and reports for new equipment as per cGMP requirements; work on equipment qualification activities as per cGMP requirements, SOPs, VMP and as per schedule; troubleshoot and investigate any equipment malfunction or inefficiencies and assist vendors/manufacturers in developing custom solutions;actively monitor and analyze USFDA guidelines, regulations, OSHA specifications, cGMP practices etc. to design and update process changes and facility plans; install and regularly update advanced software on all our sophisticated equipment regularly etc. among others. Bachelor’s degree or foreign equivalent in mechanical engineering or related field and 2 years relevant work experience in the pharmaceutical industry required.

Multiple positions open.

Annual salary: $82,000.

Ref: EE, Sciegen Pharmaceuticals Inc.,
89 Arkay Drive, Hauppauge, NY 11788.