Senior Engineer

3 weeks ago

Thousand Oaks, United States Infotree Global Solutions Full time

Ideal Candidate: minimum chemical, mechanical, Biomedical*** Bachelor degree and 5 years of experience, Masters and 3 years of experience. Quality and validation experience process and system ownership in pharma, works directly in a regulating environment and manufacturing. Leadership roles Project ownership, taking charge and saw through to completion, Team leads. Experienced, Quality Management Systems, Maximo, Validating QC instruments.

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Client Thousand Oaks (ATO). The Senior engineer will lead activities in alignment with Client’s Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The senior engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the senior engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and lead root cause investigations of equipment issues. The senior engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. This role will lead other engineers in root cause analysis, project management, with a safety-oriented mindset.

Top 3 Must Have Skill Sets:



• Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)

• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.

• Bachelor's degree in engineering or another science-related field with 5+ years of relevant work experience in operations/manufacturing environment



Day to Day Responsibilities:

The Engineer role will provide direct engineering technical support as follows:

• Be individually accountable for deliverables on key capital projects. This may include rationale development for improvements and identification of design requirement. In addition, translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.

• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action

• Lead in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

• Oversee and assist with development and execution of validation protocols in line with CQP and cGMP standards.

• Lead, evaluate, and manage performance of contract resources.

• Provide oversight for verification deliverables developed by outsourced/contract verification staff.

• Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout.

• Lead and assist other engineers with troubleshooting, maintenance, and project management.

• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.

• Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.

• Conduct and document periodic equipment validation reviews.

• Provide ad hoc technical support and guidance for manufacturing and maintenance

• Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)

• Participate in internal audits and assess risks in conjunction with QA.

• Develop and maintaining metrics related to equipment performance

• Triage and Own Deviations as well as lead team on quality based decisions

  • Engineer Senior

    2 days ago

    Thousand Oaks, United States Crystal Equation Full time

    Engineer Senior Top 3 Must Have Skill Sets: Background in Single Use Technologies Background in Process Engineering Project management skills Validation experience Red Flags: Poor communication HOW MIGHT YOU DEFY IMAGINATION? Youve earned your degre Engineer, Process Engineer, Operations, Senior, Leadership, Equipment, Staffing

  • Senior Manufacturing Automation Engineer

    2 weeks ago

    Thousand Oaks, United States Meet Recruitment Full time

    Exciting Opportunity: Senior Manufacturing Automation Engineer Client: Leading Global Pharmaceutical Company Location: Thousand Oaks Employment Type: Full-Time About the Role: I am currently partnering with a top-tier pharmaceutical company in their search for a Senior Manufacturing Automation Engineer. This role offers an exciting opportunity to lead...

  • Senior Manufacturing Automation Engineer

    3 weeks ago

    Thousand Oaks, United States Meet Full time

    Exciting Opportunity: Senior Manufacturing Automation Engineer Client: Leading Global Pharmaceutical Company Location: Thousand Oaks Employment Type: Full-Time About the Role: I am currently partnering with a top-tier pharmaceutical company in their search for a Senior Manufacturing Automation Engineer. This role offers an exciting opportunity to lead...

  • Senior Manufacturing Automation Engineer

    4 weeks ago

    Thousand Oaks, United States Meet Full time

    Exciting Opportunity: Senior Manufacturing Automation EngineerClient: Leading Global Pharmaceutical CompanyLocation: Thousand OaksEmployment Type: Full-TimeAbout the Role:I am currently partnering with a top-tier pharmaceutical company in their search for a Senior Manufacturing Automation Engineer. This role offers an exciting opportunity to lead automation...

  • Senior Manufacturing Automation Engineer

    4 weeks ago

    Thousand Oaks, United States Meet Full time

    Exciting Opportunity: Senior Manufacturing Automation EngineerClient: Leading Global Pharmaceutical CompanyLocation: Thousand OaksEmployment Type: Full-TimeAbout the Role:I am currently partnering with a top-tier pharmaceutical company in their search for a Senior Manufacturing Automation Engineer. This role offers an exciting opportunity to lead automation...

  • Senior Manufacturing Automation Engineer

    4 weeks ago

    Thousand Oaks, United States Meet Full time

    Exciting Opportunity: Senior Manufacturing Automation EngineerClient: Leading Global Pharmaceutical CompanyLocation: Thousand OaksEmployment Type: Full-TimeAbout the Role:I am currently partnering with a top-tier pharmaceutical company in their search for a Senior Manufacturing Automation Engineer. This role offers an exciting opportunity to lead automation...

  • Senior Manufacturing Automation Engineer

    3 weeks ago

    Thousand Oaks, United States Meet Full time

    Exciting Opportunity: Senior Manufacturing Automation Engineer Client: Leading Global Pharmaceutical Company Location: Thousand Oaks Employment Type: Full-Time A high number of candidates may make applications for this position, so make sure to send your CV and application through as soon as possible. About the Role: I am currently partnering with a...

  • Senior Engineer

    1 day ago

    Thousand Oaks, United States Aditi Consulting Full time

    Summary: The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases...

  • Validation Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CANO RELOCATION CANDIDATES LOCATION ON THE RESUMESMust be available for potential on call for Overtime looking at potentially 10-12 hours a month.Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with...

  • Validation Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CANO RELOCATION CANDIDATES LOCATION ON THE RESUMESMust be available for potential on call for Overtime looking at potentially 10-12 hours a month.Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with...

  • Validation Engineer

    3 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior Engineer Location: Thousand Oaks, CA Duration: 12 Months Description: Onsite - 100% Thousand Oaks, CA NO RELOCATION CANDIDATES LOCATION ON THE RESUMES Must be available for potential on call for Overtime looking at potentially 10-12 hours a month. Top 3 Must Have Skill Sets: Demonstrated strong communication and technical writing skills...

  • Validation Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior EngineerLocation: Thousand Oaks, CADuration: 12 MonthsDescription:Onsite - 100% Thousand Oaks, CANO RELOCATION CANDIDATES LOCATION ON THE RESUMESMust be available for potential on call for Overtime looking at potentially 10-12 hours a month.Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with...

  • Validation Engineer

    3 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Senior Engineer Location: Thousand Oaks, CA Duration: 12 Months Check below to see if you have what is needed for this opportunity, and if so, make an application asap. Description: Onsite - 100% Thousand Oaks, CA NO RELOCATION CANDIDATES LOCATION ON THE RESUMES Must be available for potential on call for Overtime looking at potentially 10-12...

  • Process Engineer

    4 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Title: Process Engineer Location: Thousand Oaks, CADuration: 12 months to begin with Job Details: As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of...

  • Associate Engineer

    3 weeks ago

    Thousand Oaks, United States Calsoft Labs Full time

    ****This role will be based out of the Client ATO/Thousand Oaks office. Building 6. We need local candidates only as the EW will need to be onsite 2-3 days a week for testing execution, based on workload. ****Engagement Manager is looking for candidates who are entry level. Not looking for candidates who are over qualified. Ideally we need candidates who are...

  • Mechanical Test Engineer

    2 days ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/ Mechanical Testing Location: Thousand Oaks, CA Duration: 01 Years Contract Top 3 Must Have Skill Sets: 1. Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies. 2. Experience working...

  • Mechanical Test Engineer

    3 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/ Mechanical Testing Location: Thousand Oaks, CADuration: 01 Years ContractTop 3 Must Have Skill Sets: 1. Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.2. Experience working...

  • Mechanical Test Engineer

    1 day ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/ Mechanical Testing Location: Thousand Oaks, CA Duration: 01 Years Contract Interested in this role You can find all the relevant information in the description below. Top 3 Must Have Skill Sets: 1. Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and...

  • Mechanical Test Engineer

    3 weeks ago

    Thousand Oaks, United States ACL Digital Full time

    Job Title: Engineer/ Mechanical Testing Location: Thousand Oaks, CADuration: 01 Years ContractTop 3 Must Have Skill Sets: 1. Strong writing and technical authorship including experience in writing test protocols, statistical data analysis, data verification, and test reports for a technical audience including regulatory agencies.2. Experience working...

  • Engineer

    3 days ago

    Thousand Oaks, United States Crystal Equation Corporation Full time

    Engineer*Onsite in Thousand Oaks, CA* Top 3 Must Have Skill Sets:Troubleshooting skillsMechanical systems expertiseAbility to analyze problems, develop and propose engineering solutions in a scientific mannerSummary:The Engineer will be joining Facilities & Engineering (F&E) group within Manufacturing and Clinical Supply organization at our company. The...