- Designs and project manages changes, improvements, new systems and or equipment.
- Prepares Change Control Records (CCRs), Design Specifications, User Requirements Specifications, System Specifications, Design documents, Drawings, and Validation Documents for improvement, planned and corrective maintenance and system or process improvements
- Leads/assists in Continuous Improvement Projects, including identification of opportunities, researches literature and vendors, prepares and presents proposals, develops and executes projects, and closes projects, all following appropriate change control methodologies
- Represents Technical Subject Matter Expert (SME) in teams assembled to specify, install, troubleshoot and maintain systems, equipment and processes
- Supports day-to-day production and maintenance activities
- Provides training support as required.
- Develops and or modifies SOPs for the Processes and Equipment.
- Participates in deviation investigations to identify root causes and define corrective and preventive actions (CA/PA).
- Creates and maintains drawings and sketches.
- Manages Technical Publications Library to ensure the relevant manuals, specifications, design information for all of our facilities, utilities, equipment and products are on hand
- Primary/First Line responsibility for operation and maintenance of the Validated Systems to maintain production capability required.
- Primary/First Line responsibility for enhancements and upgrades of manufacturing related systems to maintain production capability.
- Expertise in troubleshooting production equipment/systems
- Ability to work flexible schedule to support 24-hour operation (requires assignment on shift for 4 shift rotating days off schedule)
- PC literate with standard office application (Word, Excel, PowerPoint) competency
- Experience with maintenance and administration of both Windows-based and industrial (e.g., PLC) computer networks.
- Experience with Allen-Bradley ControlLogix and Siemens PLCs; experience with HMI software applications; experience with automating processes and equipment
- Knowledge and understanding of cGMPs including FDA, PMDA, and EU regulations; knowledge of cGMP validation requirements and techniques; experience with commissioning and validation protocol development and execution.
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Validation Engineer – Process Validation
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Takeda Lexington, United States Full timeDescription · Shire Human Genetic Therapies, Inc. is seeking a Validation Engineer – Process Validation in Lexington, MA with the following requirements: Bachelor's degree in Chemical/Biochemical/Bioprocess Engineering, Chemistry, Biochemistry, or related field or foreign academ ...
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Hire Military Talent Lexington, United StatesJob Description · Job DescriptionOur client, a growing wood products manufacturer in Lexington, NC is seeking a Manufacturing Process Engineer to join their team. · Duties IncludeEvaluate processes and workflows to identify opportunities for improvement · Meet with General Manage ...
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Washington Penn Lexington, United StatesThis is an on-site role, based in Winchester, KY. · Summary · Responsible for the leadership, direction, and performance of the Engineering activities at the plant. This position is responsible for supporting the plant operation teams to identify and implement improvement actions ...
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Parker Hannifin Corporation Parker Aerospace Group Lexington, United States· Process Engineering Intern · Location: LEXINGTON, KY, United States · Job Family · : Engineering · Job Type · : Regular · Posted · : Mar 4, 2024 · Job ID: 47159 · Job Description · The Engineering Intern will be responsible for determining and developing production processes ...
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3 weeks ago
Parker Hannifin Corporation Lexington, United StatesProcess Engineering Intern · Location: LEXINGTON, KY, United States · Job Family : Engineering · Job Type : Regular · Posted : Mar 4, 2024 · Job ID: 47159 · Job Description · The Engineering Intern will be responsible for determining and developing production processes for manufa ...
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Process Engineering Intern
3 days ago
Parker Hannifin Corporation Parker Aerospace Group Lexington, United StatesProcess Engineering Intern · Location: LEXINGTON, KY, United States · Job Family · : Engineering · Job Type · : Regular · Posted · : Mar 4, 2024 · Job ID: 47159 · Back to Search Results · Job Description · Apply Now > · Save Job · Job Saved · The Engineering Intern will be resp ...
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Braskem Careers Lexington, United StatesWith a strategy centered on people and sustainability, Braskem is engaged in contributing to the value chain to strengthen the Circular Economy. Braskem's 9,000 team members dedicate themselves every day to improving people's lives through sustainable solutions in chemicals and p ...
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Piramal Group Lexington, United StatesJob DescriptionKey Responsibilities Designs and project manages changes, improvements, new systems and or equipment. Prepares Change Control Records (CCRs), Design Specifications, User Requirements Specifications, System Specifications, Design documents, Drawings, and Validation ...
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Validation Engineer – Process Validation
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Takeda Lexington, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Wash. Penn Plas-Corp Frankfort, United StatesJob Description · Job DescriptionSummary · The Process Engineer is responsible for leading the development and optimization of manufacturing processes and practices to ensure sustainability and continuous improvement of WPP facilities and supporting processes. The role will also ...
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Activ8 Recruitment & Solutions Lexington, United StatesAn international automotive parts manufacturing company is actively seeking a Manufacturing Process Engineer to join their facility near Lexington, KY. · Responsibilities of Manufacturing Process Engineer · Analyze the current production system and plan Kaizen/improvement solut ...
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BlueWave Ventures Lexington, United StatesService Technician/Electrician (M/F/D) · Location: Bielefeld · Type of Employment: Full-time · Working Hours: 40 hours per week · About KPS Prüfservice · KPS Prüfservice is one of the leading companies nationwide in the field of electrical equipment testing. Our focus is on testi ...
Manufacturing Process Engineer - Lexington, United States - Piramal Group
Description
Job DescriptionKey Responsibilities
Education Requirements:
Bachelor's degree in Mechanical, Electrical, or Chemical Engineering
Work Experience:
Minimum 3-5 years of pharmaceutical manufacturing/maintenance experience required (parenteral/sterile filling experience preferred)
Functional or Technical Skills:
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About the Team
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
