Operations Engineer Aprecia Pharmaceuticals
THIS JOB HAS EXPIRED Job ID8
OverviewThe Operations Engineer provides the technical engineering support for Aprecia?s solid dosage development and manufacturing facility.
The individual will support, and at times lead, the trouble shooting, modification and improvement/upgrade of manufacturing, processing, utilities and facilities equipment and systems. Additionally, he/she will generate and execute various engineering and validation documents associated with manufacturing and facility improvements and equipment purchases.
The objective is to ensure products are manufactured in an environment which focuses on safety, quality and effective manufacturing, utility, and facility processes.
Description of Duties1.Utilize technical knowledge to identify and recommend process improvements and plant modifications to improve the safety, reliability and operability. Provide engineering support pertaining to plant design, plant modifications, process improvements, risk analysis and troubleshooting.
2.Provide support and oversight of plant related engineering projects and upgrades to existing facilities. Manage engineering projects with respect to equipment and systems for the existing facilities. Provide information, data and support as required by management for site improvements and assist in the review, monitoring and coordination of projects.
3.Assist with or lead (as required) technical investigations of non-conformance or mechanical problems and develop corrective and preventative action plans to provide practical manufacturing solutions in compliance with regulatory requirements.
4.Provide technical support to the maintenance department, driving initiatives to improve maintenance performance and equipment operability.
5.Prepare and execute technical and quality documents for facility improvements and equipment purchases. These include, but are not limited to, user requirements, functional specifications, factory/site acceptance testing, commissioning and validation protocols.
6.Preparation of capital project approval documentation, bid packages and oversight contractors in the coordination of projects.
7.Prepare appropriate change control documentation as required for modifications to qualified systems.
8.Prepare and review preventative maintenance procedures on equipment and systems.
9.Prepare and review operational and equipment SOPs.
10.Serve as a member of the site safety team and provide technical assistance for remediation of identified safety issues and concerns.
11.Assist in the establishment and maintenance of sound engineering documentation and drawing record keeping and procedures.
Minimum Requirements?Five years of experience as a Plant/Operations Engineer in a Pharmaceutical, Vitamin or equivalent process related industry. Previous experience in a GMP manufacturing environment is a plus.
?B.S. degree in Chemical or Mechanical Engineering.
?Technical knowledge of the operation, monitoring and maintenance of utility systems including HVAC, clean compressed air, low pressure steam, chillers, etc.
?Technical knowledge of the operation, monitoring and maintenance of pharmaceutical solid dosage processing and packaging equipment.
?Knowledge of process control techniques, maintenance procedures and safe work practices.
?Working knowledge of engineering codes and standards.
?Knowledge of regulatory rules and documentation requirements that relate to facilities upgrades/qualifications and equipment purchase, installation, qualification and validation.
?Strong problem-solving and critical thinking skills.
?Excellent communication, writing, presentation and data organization skills.
?Demonstrated interpersonal qualities with the ability to participate and/or lead (as needed) cross functional teams.
?Proficiency in Excel, Word and PowerPoint as well as Microsoft Project.
State/ProvinceNew Jersey NJ
Amount of TravelLess than 25%
||East Windsor, NJ |
THIS JOB HAS EXPIRED