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Sr Engineer--(Pharma or Biotech, Equipment's troubleshooting and investigations)

Company: Infotree Service Inc
Location: Thousand Oaks
Posted on: May 3, 2021

Job Description:

Company DescriptionBio-TechJob DescriptionDay to Day Responsibilities: 1. Respond to equipment issues in the manufacturing plant.2. Provide equipment expertise to troubleshoot and support investigations.3. Support equipment/process improvements Responsibilities 1. Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation2. Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. Experience with Lyophilizers a plus.3. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)The Sr. Engineer will be joining Facilities & Engineering (F) group within Manufacturing and Clinical supply organization at client. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably.Responsibilities include: Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Directing and coordinating equipment maintenance as necessary to ensure systems are in proper working order. Ensure necessary commissioning and qualification of systems is completed and interact with inspectors as necessary. Monitor systems to identify performance risks and implement risk reduction strategies. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.QualificationsDoctorate or Master Degree - 3 years of engineering experienceBachelors Degree - 5 years of engineering experienceAssociate Degree - 10 years of engineering experience*Must have strong experience within Pharma or Biotech Industry - no exceptions*Candidate will work on siteAdditional InformationTop 3 Must Have Skill Sets: 1. Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation2. Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.3. Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)Job Location

Keywords: Infotree Service Inc, Thousand Oaks , Sr Engineer--(Pharma or Biotech, Equipment's troubleshooting and investigations), Other , Thousand Oaks, California

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