Description: The Associate Process Engineer provides support to the operation Manager/Associate Director Operation/ Engineering in implementing improvements, validation and automation to the plant operations and assist i…
Skills: Process Engineering, Equipment Validation, Standard Operating Procedures, Process Optimization, Data Analysis
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$22/hr–$32/hr
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$65k–$80k/yr
Full-time
bachelor degree, postgraduate degree
Health Insurance, Insurance Benefits, 401(k) Matching, Short-term Incentive Opportunity, Performance-based Award
Posted 7h ago
~40 hrs/week
Responsibilities
The Associate Process Engineer supports plant operations by implementing process improvements, equipment validation, and automation. They also assist in drafting standard operating procedures, analyzing manufacturing data, and investigating process deviations to ensure compliance with cGMP and FDA regulations.
Requirements
Candidates must hold at least a Bachelor's degree in Engineering, Pharmaceutics, or a related field. A minimum of one year of experience in Engineering or Pharmaceutics is required for this role.
Full job description
Description:
The Associate Process Engineer provides support to the operation Manager/Associate Director Operation/ Engineering in implementing improvements, validation and automation to the plant operations and assist in several functions such as writing standard operating procedures (SOPs), develop process flow, review design documents related to procurement of new equipment. Help with equipment validation.
Night Shift – 12-hour per day, rotating schedule (6:00pm-6:30am) 3 days on week 1 and 4 days on week 2 of pay cycle
Essential Functions:
Support process/validation engineer; for plant operations to suggest and implement improvements; for new manufacturing processes through process and equipment validation.
This entails completing process simulations and optimization studies and implementing modifications and process installations at the manufacturing level
Support day-to-day manufacturing operations by monitoring process performance and identifying improvement opportunities.
Assist in process optimization to improve yield, efficiency, quality, and equipment reliability.
Analyze manufacturing data using statistical and analytical tools to drive data-based decision making
Help prepare and update Standard Operating Procedures (SOPs) and help execute equipment installation and operational qualifications, validation protocols, reports, and change controls.
Supports technical services by troubleshooting activities in the operation department. Protocol review and Development process
Help generate reports, charts, and tables based on established statistical methods to drive process enhancements.
Investigate process deviations and non-conformances; perform root cause analysis (RCA) and support CAPA implementation.
Assist process/validation engineer evaluate, improve and validate current manufacturing practices or processes and equipment’s with an effort for continuous improvement towards productivity, quality, reliability and consistency.
Provide support on various manufacturing/engineering equipment uptime.
Ensure compliance with FDA regulations, cGMP requirements, and internal quality standards.
Collaborate with cross-functional teams to support continuous improvement initiatives and regulatory readiness. Communicate with vendors on possibility of material improvement.
Additional Responsibilities:
Other duties that management may from time to time assign
Write deviation and CAPA (Corrective action and preventive action
Assist review of process related documents
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected]. Requests will be handled confidentially and in accordance with applicable laws.
Related keywords
Process EngineeringValidationAutomationSOPManufacturingEquipment QualificationStatistical AnalysisRoot Cause AnalysisCAPAFDAcGMPQuality StandardsTechnical ServicesProcess OptimizationYield ImprovementReliability
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
Offices: 400 Crossing Boulevard, Bridgewater, New Jersey 08807, US