inSync Staffing
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$36.00/hr - $47.00/hr Job Responsibilities: Develop and implement
novel approaches
to solving complex operational problems while maintaining safety, quality, and production standards. Drive process improvement initiatives to enhance efficiency, reduce waste, and ensure compliance with regulatory requirements. Lead
root cause analysis (RCA) and structured problem-solving
sessions to identify and address unplanned events, reducing recurring issues. Optimize manufacturing processes through
Lean principles, Overall Equipment Effectiveness (OEE), and Six Sigma methodologies . Support and enhance
tech transfers and process resolutions
to improve Fill Finish manufacturing operations. Compliance & Regulatory Support Own and actively manage
deviations, change records, and compliance actions
related to operational activities, procedures, and processes. Perform
technical and operational reviews
of documentation related to process design, validation, operation, and maintenance. Serve as a
Subject Matter Expert (SME)
and provide technical support during regulatory inspections. Ensure compliance with
current Good Manufacturing Practices (cGMPs) , sterility assurance, and industry best practices in aseptic processing. Data Analytics & Business Insights Interpret customer and business needs to develop
data-driven solutions
and process models. Build analytical tools using
structured and unstructured datasets
to automate data analytics and track key performance indicators. Present data-driven insights to stakeholders, driving informed decision-making and business improvements. Manufacturing Readiness & Equipment Optimization Manage
product transfers and new equipment/process start-up , including manufacturing readiness, process design, document development, engineering runs, and equipment setup. Provide technical guidance on
aseptic manufacturing equipment , including isolators, filling machines, inspection & packaging systems, and sterilization technologies. Review and resolve
operational and process discrepancies
to enhance manufacturing efficiency and product quality. Lead coordination and
issue resolution
across HTO Manufacturing Operations, support teams, and cross-functional projects. Actively participate in
customer support meetings
and strategic discussions related to process improvements. Coach and mentor
technicians, leaders, and peers
on topics such as
Lean, OEE, RCA, and project/program management . Who You Are Minimum Qualifications: Bachelor’s degree
in
Life Sciences, Physical Sciences, Engineering,
or an equivalent combination of education and experience. 5+ years of experience
in the pharmaceutical industry with progressive responsibility. Strong
problem-solving skills
with a track record of troubleshooting and resolving process-related issues while ensuring regulatory compliance. Experience working with
large datasets
(structured and unstructured), deriving actionable insights, and presenting findings to stakeholders. Deep understanding of
quality systems, cGMPs, and aseptic processing regulations . Working knowledge of
aseptic manufacturing principles , including sterility assurance, microbiology, and regulatory guidelines. Experience with
manufacturing process equipment
such as isolators, filling, inspection, and packaging machines. Ability to work independently within broad guidelines, requiring guidance only in complex situations. Strong
stakeholder management and influencing skills , even in scenarios without direct managerial authority. Preferred Qualifications: Experience in
continuous improvement initiatives
related to process, equipment, and quality systems. Knowledge of
Lean Manufacturing, Six Sigma, and other operational excellence methodologies . Benefits: Health insurance Health savings account Vision insurance Flexible spending accounts Life insurance All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Seniority level
Mid-Senior level Employment type
Contract Job function
Industries Staffing and Recruiting
#J-18808-Ljbffr
$36.00/hr - $47.00/hr Job Responsibilities: Develop and implement
novel approaches
to solving complex operational problems while maintaining safety, quality, and production standards. Drive process improvement initiatives to enhance efficiency, reduce waste, and ensure compliance with regulatory requirements. Lead
root cause analysis (RCA) and structured problem-solving
sessions to identify and address unplanned events, reducing recurring issues. Optimize manufacturing processes through
Lean principles, Overall Equipment Effectiveness (OEE), and Six Sigma methodologies . Support and enhance
tech transfers and process resolutions
to improve Fill Finish manufacturing operations. Compliance & Regulatory Support Own and actively manage
deviations, change records, and compliance actions
related to operational activities, procedures, and processes. Perform
technical and operational reviews
of documentation related to process design, validation, operation, and maintenance. Serve as a
Subject Matter Expert (SME)
and provide technical support during regulatory inspections. Ensure compliance with
current Good Manufacturing Practices (cGMPs) , sterility assurance, and industry best practices in aseptic processing. Data Analytics & Business Insights Interpret customer and business needs to develop
data-driven solutions
and process models. Build analytical tools using
structured and unstructured datasets
to automate data analytics and track key performance indicators. Present data-driven insights to stakeholders, driving informed decision-making and business improvements. Manufacturing Readiness & Equipment Optimization Manage
product transfers and new equipment/process start-up , including manufacturing readiness, process design, document development, engineering runs, and equipment setup. Provide technical guidance on
aseptic manufacturing equipment , including isolators, filling machines, inspection & packaging systems, and sterilization technologies. Review and resolve
operational and process discrepancies
to enhance manufacturing efficiency and product quality. Lead coordination and
issue resolution
across HTO Manufacturing Operations, support teams, and cross-functional projects. Actively participate in
customer support meetings
and strategic discussions related to process improvements. Coach and mentor
technicians, leaders, and peers
on topics such as
Lean, OEE, RCA, and project/program management . Who You Are Minimum Qualifications: Bachelor’s degree
in
Life Sciences, Physical Sciences, Engineering,
or an equivalent combination of education and experience. 5+ years of experience
in the pharmaceutical industry with progressive responsibility. Strong
problem-solving skills
with a track record of troubleshooting and resolving process-related issues while ensuring regulatory compliance. Experience working with
large datasets
(structured and unstructured), deriving actionable insights, and presenting findings to stakeholders. Deep understanding of
quality systems, cGMPs, and aseptic processing regulations . Working knowledge of
aseptic manufacturing principles , including sterility assurance, microbiology, and regulatory guidelines. Experience with
manufacturing process equipment
such as isolators, filling, inspection, and packaging machines. Ability to work independently within broad guidelines, requiring guidance only in complex situations. Strong
stakeholder management and influencing skills , even in scenarios without direct managerial authority. Preferred Qualifications: Experience in
continuous improvement initiatives
related to process, equipment, and quality systems. Knowledge of
Lean Manufacturing, Six Sigma, and other operational excellence methodologies . Benefits: Health insurance Health savings account Vision insurance Flexible spending accounts Life insurance All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Seniority level
Mid-Senior level Employment type
Contract Job function
Industries Staffing and Recruiting
#J-18808-Ljbffr