Sr. Process Engineer

Vista, CA, US
Sep 14, 2019
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Your Responsibilities

The Senior Process Engineer/Project Lead is responsible for plans, design, development,

implementation, and analysis of technical products, manufacturing processes and systems in an

industrial plant with consideration of safety. Performs engineering design evaluations. Recommends

alterations to development and design to improve quality of products, process and/or procedures.

Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force

utilization. Determines parts and tools needed in order to achieve manufacturing goals according to

product specification. Lead project team and drive project milestones to design, develop, project, and

improve processes materials flow.

Your Tasks

Responsible for Design, installation, and qualification of batch processing tanks, solvent recovery system (Linde), filter dryers, HPLCs, filtration system, Lyophilizers, ultra-low freezers, HVAC, solvent distribution and recovery system, compressed air, purified water, and waste water system

Lead technical activities associated with the development and qualifications of new production line and equipment

Collaborate with Production and Controls Team to develop and streamline production process in automating the new and existing system by harmonizing and leveraging developed technology.

Develop and train cross-functional team members on utilization and maintaining new equipment and system - by creating roadmap, improving existing process, creating new procedures, job aids, SOPs and protocols as well as training of staff for these expectations

Lead and support site development and production capacity expansion efforts

Develop process and provide guidance for to improve engineering and project programs

Troubleshoot process equipment, and monitor and trend to ensure that equipment works to its specifications and appropriate capacities

Perform process development and performance trending studies for new and existing equipment and system in support of the site preventive maintenance and continuous improvement effort

Lead engineering team and coordinates engineering activities to design, develop, and execute strategic investment projects, and improve process material flow

Lead activities to design new processes, modify existing designs, improve production techniques, and develop test procedures

Your Profile

Bachelor's Degree in Engineering

Minimum of 7 years' relative work experience

Working Knowledge of ASTM and ASME BPE Standards and Industry Code as it relates to Chemical, Pharmaceutical facilities or related facilities

Working Knowledge of cGMP, GDP, GEP engineering principles

Knowledge of CalOsha Title 8, California Building Code (CBC), AQMD & APCD rules, and FDA title 21

Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.)

Successful track record in design, planning and project management of manufacturing or pilot plant facility expansions

Handle complete project life cycle from design, planning and implementation to validation including master site planning and funding package development

Experience in handling hazardous materials and chemicals

Excellent written and oral communication skills

Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment

Detail oriented with the ability to troubleshoot and resolve problems.

Ability to work independently, manage one's time, and function well in a team environment

Ability to communicate effectively in a proactive and solution-focused manner, including keeping management aware of potential issues

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.

Nearest Major Market: San Diego