Process & Cleaning Validation Specialist, Technical Services
$80k - $90kMerck & Co.
Description Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects. Essential Functions Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study. Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects. Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements Coordinate/oversee the development of new processes or troubleshoot existing ones Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits Additional Responsibilities Initiation of Change Controls and Planned Deviations when required Education Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred Experience 2 years or more in Pharmaceutical/Manufacturing Industry Skills Excellent verbal and written communication skills - Advanced Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced Specialized Knowledge Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals. The base salary for this position ranges from $80,000 to $90,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities. #J-18808-Ljbffr Merck & Co.
$81.47k - $122.21k
...- Revolutionizing wafer fabrication processes for enhanced efficiency and performance... ...comprehensive range of high-quality solutions and technical services enables the entire electronics supply... ...capability studies, and process validation approaches. Collect, organize, and...SuggestedFor contractorsLocal areaWorldwide- ...Manufacturing Process EngineerLIGHTERA has one of the longest and most respectable corporate... ...for our customers, with exceptional service that creates value for our shareholders,... ...safety policies and procedures, maintaining a clean, organized work area, wearing, and...SuggestedWorldwide
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- ...Lead Process EngineerPerform the following job duties in a premium metal credit card manufacturing... ...production costs.Prepare and present technical proposals and improvement plans to... ...(NPI) activities, including process validation, work instruction development, and ramp-...Suggested
- ...Process Engineer IThe Process Engineer I ensures manufacturing processes are efficient, cost-effective, compliant with MICRO's quality... ...and data analysis that enhance process understanding, enable validation, and ensure manufacturing consistency.Assist in root cause...
$90k - $210k
...Senior Process EngineerWe are seeking an innovative and highly motivated Senior Process... ...sites or directly from customersLead Master Validation Plan creation in order to support PPQ... ...feedback on internal software solutionsProvide technical support to Manufacturing and other...Flexible hours- ...contract manufacturer providing services for companies engaged in... ...Are you ready to? The Process Engineer II is responsible to... ...conducting DOEs, performing Validations, executing Implementations,... ...these instructions and other technical process controls (quality engineer...Contract work
- ...Industrial Blenders/Mixers in Central New Jersey is seeking a Process Engineer. We are seeking a Process Engineer with a strong Chemistry... ...seamless integration of new processes. Develop and maintain technical documentation, including regulatory documents and records,...
$95.41k - $143.11k
MacDermid Alpha Electronics Solutions in Piscataway Township, New Jersey, is seeking an Engineer to optimize chemical processes within the Global Process Engineering Group. The ideal candidate will have at least 5 years of experience in chemical process development and...- A leading technology services company is looking for an Associate Process Engineer/Scientist specializing in Drug Product within Biologics Manufacturing. Responsibilities... ...manufacturing processes, and serving as a technical resource across teams. Candidates should have a...
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- Gemco is seeking a Process Engineer in Middlesex, New Jersey, to optimize manufacturing processes and ensure regulatory compliance. The ideal candidate will have a Bachelor's degree in mechanical or chemical engineering and at least 5 years of relevant experience. Key responsibilities...
$109k - $164k
...looking for? We are seeking an experienced Process Engineer with deep expertise in chemical... .... The ideal candidate is a strong technical leader who excels in developing P&IDs, executing... ...&IDs and support pilot studies, process validation, and troubleshooting Optimize processes...Local area- ...module] work plans for delivery and also provide technical guidance for work completion. (1.) To ensure process improvement and compliance in the assigned module... ...requirement:"Strong expertise in Computer System Validation (CSV) processes and methodologies, ensuring compliance...
- International Flavors & Fragrances Inc. is seeking a Process Engineer for onsite work in South Brunswick, NJ. The role focuses on designing, planning and executing lab and pilot-scale experiments to support new product development and process improvements. You will collaborate...
$80k - $90k
...lasting contribution to help grow iconic snack and confectionery brands, no matter your area of expertise. We are looking for a Process Engineer interested in a career with a top ranked and growing snack company, to join our R&D department at PIM's Somerset site, New...Full timeCasual workWork at officeImmediate startFlexible hoursShift work- ...R&D Process EngineerSomerset - Somerset, NJ 08873OverviewSalary Range $80,000.00 - $90,000.00 Salary Position Type Full Time Job Shift Office 8:30AM-5PM Education Level 4 Year Degree Travel Percentage None Category ResearchDescriptionDo you love snacks? Are you looking...Full timeCasual workWork at officeImmediate startFlexible hoursShift work
- ...applications ranging from automotive R&D, process and environmental monitoring, in-vitro... ...to existing processesQualification and validation of new processes/products and of changes... ...changes to process/materials/equipment; technical support of the sales team when needed.Skills...Temporary workWorldwideFlexible hours
- ...Responsibilities: Develop and document assembly processes using Lean Manufacturing methodologies. This will include complete documentation... ...Training technicians on assembly and test process. Validate technicians on competency to assembly & test process Requirements...
- ...neuroscience - and products and services in our Allergan... ...is to provide technical support to cross-functional... ...engineering and product/process knowledge, and... ...products. Assist in the validation of new and revised manufacturing... ...: Process Validation, Cleaning Validation, Equipment...Temporary workWork at officeLocal areaImmediate start
$109k - $164k
Element Solutions Inc is looking for an experienced Process Engineer in Piscataway Township, NJ, to lead the design and scale-up of chemical... ...cross-functional collaboration. This role requires a strong technical leader with a Bachelor's degree in Chemical Engineering and at...- ...build a better world.Job Description:Validation Engineer Who You’ll Work With You will... ...and partner with seasoned leaders, technical specialists, and subject matter experts to deliver... ...assist in the design of manufacturing processes, help manage projects, develop...Full timeWork at officeFlexible hours
- ...understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. * Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems * Create and modify validation...
$105.5k - $243k
HPEFS Sr. Process EngineerThis role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE office... ...Berkeley Heights, NJ on a hybrid schedule.About the RoleHPE Financial Services within HPE is seeking a highly experienced individual...Full timeWork experience placementWork at officeLocal areaImmediate start$94.1k - $129.4k
...education among other factors. In addition, this position is eligible for an incentive bonus. The purpose of the Process Engineer's role will be to provide technical leadership to operate a major asset (typical annual revenue of $50MM to $200MM) at target regarding output,...Full timeTemporary workFlexible hours$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in Raritan, NJ. Exempt level... ...equipment, systems, computer systems, and processes within a cell therapy manufacturing... .... Interact with Quality and Technical Services to assess and guide deployment of systems...Work at officeFlexible hours- ..., NJ is seeking a Manufacturing Quality Specialist to join their team. Must have a minimum... ...person will play a key role in implementing process improvements within an efficient ISO-900... ...development and execution of process validation and verification test plans, protocols,...Work experience placement
$48 - $52.88 per hour
...position involves documenting manufacturing processes with procedures and work instructions,... .... The engineer will develop and validate test fixtures, train technicians on new... ...support OEM business development and provide technical support to the sales team in pre-sale situations...Contract workTemporary work$76k - $96.5k
...analysis and resolution to keep builds on track.Identify design or process issues encountered on the floor and provide clear feedback to... ...related to manufacturability, assembly sequence, and serviceability of complex equipment.Travel up to approximately 10% domestically...Permanent employmentRelocationShift work
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