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Associate Director, Operations Engineering - United States  

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Posted on : 03 June 2017

Project Description

Company Statement

For nearly 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Responsibilities

BASIC SUMMARY:

Manage the operational engineering aspects of production pertaining to the manufacturing and packaging of endotoxin analytical diagnostic reagents.  This will include equipment, process, and automation engineering, as well as, capital project management and validation. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Proven experience in the leadership of an engineering organization within a cGMP environment including experience in troubleshooting equipment and material/component related challenges to improve operational efficiency and sustainability.
  • Capital project justification and implementation including cost savings rationale, new product introduction, equipment replacement/upgrade, etc.  Demonstrated execution of complex capital projects, equipment and facility design engineering, system/area start-up, etc.
  • Demonstrated track record of success leading multiple projects simultaneously with minimal direction and strong engineering project management discipline.
  • Knowledge of various unit operations/technologies (i.e. lyophilization, liquid filling, vision systems, packaging, etc.)
  • Knowledge of regulatory standards applicable to Class 100 cleanroom operations, processes, facilities, and validation.  Experience with facility and equipment design for flexibility and compliance with cGMP along with direct interaction with regulatory agencies during inspections.
  • Knowledge of designing and implementing an equipment preventative maintenance program, spare parts management, equipment reliability program, metrology/calibration, etc.
  • Knowledge of automated process control systems, experimental design/statistical analysis, and process optimization.
  • Continuous improvement background with knowledge of Lean Manufacturing/Six Sigma/OE tools, FMEA, and data analysis techniques.
  • Competency in technical writing/review for preparation and execution of cGMP related documentation including plant trials, technical reports, user requirement specifications, design qualifications, equipment commissioning/qualification, validation, equipment FAT/SAT, and process development.
  • Demonstrated knowledge of equipment, process, and computer validation including product lifecycle management, risk assessment, change control management, etc.
  • Demonstrated ability to lead problem solving/trouble-shooting of equipment and processes including root cause analysis, deviation investigation, corrective/preventative actions, etc.
  • Accountable for a team of engineers associated with equipment, process, automation, metrology, validation, etc. with the ability to collaborate with internal/external cross-functional teams to promote and lead safety programs, quality initiatives, process/equipment robustness improvements, facility upgrades, etc.
  • Development and implementation of on-the-job training (OJT) / job instruction (JI) processes.
  • Perform other related duties as assigned.

Qualifications

  • Education:  Bachelor of Science degree in engineering (prefer mechanical or chemical)
  • Experience:   Minimum of 10 years of related experience within a manufacturing facility and demonstrated proficiency in leading projects within a team environment.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure:  None
  • Other:  Effective communication and interpersonal skills required.  Demonstrated computer skills (data input, word processing) required.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.  Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015. 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016.

For more information, please visit www.criver.com.

Equal Employment Opportunity

Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet