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Job Title: Analytical Engineer
Pay Rate: $37 - $41 / hr
Location: Thousand Oaks, CA
Area Code: 805
ZIP Code: 91320
Start Date: Right Away
Shift: 1st shift
Keywords: #AnalyticalEngineer #EngineeringJobs
Benefits:
* Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
* On the job training / cross-training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.
* Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
* Scheduled performance reviews create opportunities for advancement and pay increases.
* We have many success stories from individuals who took advantage of the training, cross-training, and personal development opportunities for advancement. We also have success stories of individuals who desired a reliable, scheduled and consistent career with appropriate work-life balance, health benefits and good job security. Whichever way you define success, this work culture cares about team members and treats each individual with dignity, inclusion, respect and recognition.
* A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.
Responsibilities:
*Accountable for the verification deliverables on key capital projects.
*Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
*Oversee development 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.
*Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
*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.
*Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)
* Participate in multidisciplinary teams
* Support Lean Transformation and Excellence in Operations process improvement
* Provide ad hoc technical support and guidance for manufacturing
* Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
* Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
* Participate in internal audits and assess risks in conjunction with QA.
* Assist in developing and maintaining metrics related to equipment performance
* Provide technical expertise to develop reliability improvement plan including design requirements, maintenance strategy, spare part procurement.
* Lead improvement implementation plans while following safety requirements
* Assist with equipment maintenance and troubleshooting during project duration
* Introduce and implement new analytical systems to improve reliability when needed.
* Lead implementation plan
* Contact vendors as needed to understand and assess any change impact (to equip, utility, facility) as improvements are planned and executed.
* Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.
Requirements:
*Bachelor's degree in Engineering
*2+ years of relevant work experience in operations/manufacturing environment
*Fundamental Technical Knowledge ****ANALYTICAL ENGINEER
*Experience with regulated environments (FDA, OSHA, EPA, etc.)
*Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
*Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
*Experience in developing SOPs and delivering training
* Demonstrated strong communication and technical writing skills
* Strengths in facilitation and collaboration / networking with cross-functional groups
* Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
* Problem solving skills
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at http://www.belcan.com
Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the engineering, IT, and professional fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at http://www.belcan.com.
Pay Rate: $37 - $41 / hr
Location: Thousand Oaks, CA
Area Code: 805
ZIP Code: 91320
Start Date: Right Away
Shift: 1st shift
Keywords: #AnalyticalEngineer #EngineeringJobs
Benefits:
* Medical / Health Benefits with multiple plan options, Flexible Spending Accounts, Dental and Vision / glasses / prescription contact lens and eye test options available.
* On the job training / cross-training to develop and expand skills, creating opportunity for advancement and personal development. Tuition reimbursement available for relevant development opportunities.
* Life Insurance, disability insurance, and voluntary life insurance for family members available. Accident and critical illness insurance optional.
* Scheduled performance reviews create opportunities for advancement and pay increases.
* We have many success stories from individuals who took advantage of the training, cross-training, and personal development opportunities for advancement. We also have success stories of individuals who desired a reliable, scheduled and consistent career with appropriate work-life balance, health benefits and good job security. Whichever way you define success, this work culture cares about team members and treats each individual with dignity, inclusion, respect and recognition.
* A Referral Program compensates active employees for referring friends and former colleagues when the referral results in hiring the person. Our team has grown with referrals and internal promotions.
Responsibilities:
*Accountable for the verification deliverables on key capital projects.
*Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
*Oversee development 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.
*Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
*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.
*Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)
* Participate in multidisciplinary teams
* Support Lean Transformation and Excellence in Operations process improvement
* Provide ad hoc technical support and guidance for manufacturing
* Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
* Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
* Participate in internal audits and assess risks in conjunction with QA.
* Assist in developing and maintaining metrics related to equipment performance
* Provide technical expertise to develop reliability improvement plan including design requirements, maintenance strategy, spare part procurement.
* Lead improvement implementation plans while following safety requirements
* Assist with equipment maintenance and troubleshooting during project duration
* Introduce and implement new analytical systems to improve reliability when needed.
* Lead implementation plan
* Contact vendors as needed to understand and assess any change impact (to equip, utility, facility) as improvements are planned and executed.
* Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.
Requirements:
*Bachelor's degree in Engineering
*2+ years of relevant work experience in operations/manufacturing environment
*Fundamental Technical Knowledge ****ANALYTICAL ENGINEER
*Experience with regulated environments (FDA, OSHA, EPA, etc.)
*Knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
*Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
*Experience in developing SOPs and delivering training
* Demonstrated strong communication and technical writing skills
* Strengths in facilitation and collaboration / networking with cross-functional groups
* Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
* Problem solving skills
If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at http://www.belcan.com
Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract/temporary, temp-to-hire, and direct assignments in the engineering, IT, and professional fields. We are the employer of choice for thousands worldwide. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a team-driven Equal Opportunity Employer committed to workforce diversity. For more information, please visit our website at http://www.belcan.com.
