Senior Engineer - Biotechnology / Medical Device / Pharmaceutical

Employer
Ronin Staffing, LLC
Location
Thousand Oaks, CA
Posted
Jul 14, 2017
Jobs Outside Higher Education
Businesses & Consultants
Institution Type
Outside Academe


Job Description

Job Title: Senior Engineer

Location: Thousand Oaks, CA 91320

Job Description:

• System Owner of biotech processing equipment for the Thousand Oaks operations.

• The candidate will be part of an engineering group that is responsible for applying engineering skills and experience to ensure the reliability, safety, and quality compliance of manufacturing and utility equipment for.

• Specifically, the candidate may own a combination of process tanks, rotating equipment such as pumps, agitators, and educators, chromatography systems, glass-washers, autoclaves and parts washers, clean-in-place skids and equipment, and associated valves and instrumentation.

• Duties and tasks associated with system ownership include providing engineering expertise to manufacturing and maintenance, developing and/or revising maintenance strategies, plans, and procedures, overseeing equipment startup tasks, leading troubleshooting investigations, supporting safety/compliance investigations, providing technical support to engineering projects, and managing equipment projects on a small scale.

• System owners must work closely with multiple disciplines including manufacturing, quality, maintenance crafts, utility operators, and validation. A background in a regulated environment is helpful since all duties and tasks must adhere to approved procedures and FDA Code of Federal Regulations.

• This position really lends itself to a Chemical Engineer.

• As a member of the Engineering, Facilities, and Reliability organization, this position will be responsible for delivering engineering services in a biopharmaceutical manufacturing facility.

• Responsibilities include: Application of engineering principles to ensure that the manufacturing production goals and targets are met.

• Support of new technology introductions by performing engineering assessments, implementing equipment modifications, and leading/delivery NTI projects.

• Ensure the logical, systematic translation of design requirements and constraints into process equipment/system solutions.

• Assist with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.

• Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)

• Represent clinical operations within key corporate networks and teams

• Lead implementation of key department goals and initiatives

• Support site capital projects and programs as necessary

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

• Basic Qualifications Doctorate degree

• OR

• Master's degree and 3 years of engineering experience

• OR

• Bachelor's degree and 5 years of engineering experience

• OR

• Associate's degree and 10 years of engineering experience

• OR

• High school diploma / GED and 12 years of engineering

• Preferred Qualifications Bachelor's degree in Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Electrical Engineering, Computer Science or Mechanical Engineering

• 5+ years of engineering experience with in an operations/manufacturing environment

• Demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices

• Ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields

• Ability to employ advanced techniques within area of engineering expertise.

• Multi-disciplinary engineering background/experience

• Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)

• Detailed understanding of industry regulations and ability to interpret in establishing current practices.

• Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.

• Ability to apply engineering principles to the design and implementation of system modifications, introduction of new processes. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

• Strong leadership, technical writing, and communication/presentation skills.

• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

• Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, non-conformances, corrective and preventative actions, and validation practices.

• Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.

• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Top 3 Must Have Skill Sets:

• Process equipment design and troubleshooting experience

• Knowledge of operating in GMP environment

• Analyze problems and develop engineering solutions

Day to Day Responsibilities:

• Application of engineering principles to ensure that the manufacturing production goals and targets are met.

• Support of new technology introductions by performing engineering assessments, implementing equipment modifications, and leading/delivery NTI projects.

• Ensure the logical, systematic translation of design requirements and constraints into process equipment/system solutions.

• Assist with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.

• Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)

• Represent clinical operations within key corporate networks and teams

• Lead implementation of key department goals and initiatives

• Support site capital projects and programs as necessary Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.



Thousand Oaks, CA

bbe5db5f10

Thu, 13 Jul 2017 16:35:44 PDT

PI98686851