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Packaging Engineer Salary in State of New York, USA

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Must be able to resolve conflicts between requests for process change and the validation requirements for those processes. Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred. Independent self-starter who is capable of planning schedules, controlling plans, and leading projects as assigned. Must ensure adherence to FDA and ISO requirements throughout the product life cycle. Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO requirements.Ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and support personnel, and solving project-related conflicts and issues. Strong working knowledge of design and process controls. Travel when required to support business projects as a validation representative.Knowledge of process and product risk assessments.Knowledge of global regulatory and quality requirements associated with medical devices. Working knowledge of ISO 13485 and 21 CFR Part 820.Experience with formal problem solving in a team environment.Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. 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We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Master's degree is a plus.Experience• Minimum 5 years' of industry-related experience• Strong proficiency with packaging industry design and test standards (ISTA, ASTM, etc.)• Experience in regulated industry with a knowledge of sterile barrier packaging and sterilization processes.• Solid understanding of low particulate and low bioburden medical device packaging, manufacturing practices, and test methods• Experience with leading packaging equipment process qualifications (IQ, OQ, PQ)• Execution of project qualification activities and closeout.• Experience with structural engineering analysis of new packaging designs• Proficient in Microsoft Office applications• Solidworks (CAD), ArtiosCAD, CAPE (pallet layout), and SAP (ERP) experience.• Container leak testing experience• Willing to travel domestically and internationally (10%)• Analytical nature, responds positively to challenges, and a problem-solver• Highly motivated, organized, and detailed oriented. 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Project Engineer III
Thermo Fisher Scientific, Middletown
Job DescriptionJob DescriptionJob Title: Project Engineer IIIJob Profile Title: Engineer III, Manufacturing EngineeringReports To: Sr Manager, Manufacturing EngineeringGroup/Division: CDD/SDGJob Track: ProfessionalJob Family: OperationsJob Sub-Family: Manufacturing EngineeringJob Band Level: 06Job Code: OPS.MFGE.A06Location: Middletown, VirginiaNo. of Direct Reports: 0Day/Shift: 1st ShiftFLSA Status: ExemptWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.Location/Division Specific InformationMiddletown, VA/Specialty Diagnostics GroupDiscover Impactful Work:As a Project Engineer III you will optimally manage the execution of automation projects from a single piece of equipment to a full production line.Recommend, scope, plan, design, develop, and implement capital projects in Filling and Packaging Operations within the site.Evaluate and recommend improvements to existing processes and facilities to improve all plant metrics.A day in the Life:Maximize project efficiency and profitability.Develop scope and parameters for project design and implementation.Support Filling and Packaging Operations with technical leadership and facilitation of Root Cause Analysis, Focused Improvement and FMEA (Failure Modes Effects Analysis).Team CollaborationCollaborate in team design reviews to help develop technical solutions to meet customer requirements.Communicate during daily interactions with the project team and ensure deliverables are being met and work with management to solve roadblocks.EducationUniversity degree in mechanical or mechatronics engineering, or related science is required.PMP® certification is desired.ExperienceA minimum of 5+ years of related field experience with progressively increasing responsibilities is required.3 years related project management experience within fast-paced automated environment.Knowledge, Skills, AbilitiesParticipate in the development of Start Up planning with plant personnel to identify all additional labor requirements, scrap produced and start up inefficiencies.Develop User Requirement Specifications (URS) to review engineering & operational concepts with OEMs.Develop project timelines and achievements around plant production commitments to ensure project completion.Coordinate manufacturing launch for new or revised products/processes, including the deployment and training of team members.Responsibilities include developing validation documentation to ensure new equipment and / or processes aligns with GMP standards. (i.e., SOP, WI, URS, FAT, SAT).Promote and support Lean Manufacturing and Continuous Improvement activities within the assigned production area.Management of projects in a structured PMO environment.Proficiency using MS Project (or equivalent) and other Microsoft applications.Must be proficient in AutoCAD and SolidWorks.Development of project cost and schedule management experience.Proficiency with ERP systems (SAP preferred).Strong organizational, planning and time-management skills.Strong interpersonal skills; verbal, written, and presentation.Develops, submits, and implements CAPEX projects. Responsibilities include implementing purchase orders, ensuring invoice payments against the CAPEX are approved and working with Accounts Payable.Applies knowledge of engineering principles in connection with driving responsibilities to include process improvement, problem resolution, project management, and employee training.Hands-on experience of automation, robotics, vision systems, and other advanced manufacturing technologies.Physical Requirements / Work Environment Business casual office environment.Significant time each day spent in GMP manufacturing environment in which designated PPE will be required.Position will require sitting, standing, and climbing of stairs.Employee may occasionally lift and/or move up to 50 pounds.BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Senior Validation Engineer -Medical Device
Kelly Science, Engineering, Technology & Telecom, Middletown
Validation Staff Engineer - Medical DeviceDirect Hire (No C2C)Location: Middletown, VA 22645Salary: $120,000 -130,000 + Full Benefits Package and Bonus PotentialOverview: Our client is looking for a Validation Staff Engineer located in Middletown, VA. Their customers globally rely on their extensive range of products and services from life-saving medicines to lab essentials to next-generation instruments. The operations team leverages PPI (Practical Process Improvement Business System) to manufacture and produce these products and continuously improve productivity and quality all while contributing to the Mission - to enable our customers to make the world healthier, cleaner, and safer.Responsibilities:Responsible for leading / assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new product development, and working as part of a cross-functional team responsible for sustaining change. An active participant in the origination of design concepts and specifications, process/technology development, product verification/validation, project planning, and other applicable documentation while adhering to quality and manufacturing requirements.Serve as the primary interface between Operations and Quality Assurance.Originate and assist in the preparation and approval of change orders related to the operation and improvement of manufacturing processes.Assist the validation team in maintaining the Site Validation Master Plan.Support development projects, transfer projects, process changes, and engineering projects to provide overall guidance as it relates to quality standards, inspection techniques and FMEADirect and oversee validation activities for Operations, Engineering, Quality Assurance, and other functional areas.Review, revise, and maintain site validation procedures, qualification protocols, and associated data in accordance with FDA and ISO requirements.Lead and/or assist in training of staff involved in validation activities.Assist Quality, Operations, and Engineering personnel during inspections or audits.Requirements:Bachelor degree from a four-year college or university and 5+ years of relevant experience or in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities.Or Associate degree and 10+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities is required.Must be proficient on validation protocol development, technical writing, data analysis, and report generation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.Must have knowledge of process + packaging equipment, and software validation principles and concepts.Must have high level of expertise concerning current validation principles and regulatory requirements.Strong understanding and proficiency in cleaning validation and cleaning process design.Must be proficient in statistical analysis and process control.Must be able to resolve conflicts between requests for process change and the validation requirements for those processes.Independent self-starter capable of planning schedules, controlling plans, and leading projects as assigned.Must ensure adherence to FDA and ISO requirements throughout the product life cycle.Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO requirements.ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and support personnel, and solving project-related conflicts and issues.Strong working knowledge of design and process controls.Knowledge of global regulatory and quality requirements associated with medical devices. Working knowledge of ISO 13485 and 21 CFR Part 820.Preferred Qualifications:Proficiency in Microsoft Office products (i.e. Mini Tab, Excel, Outlook, PowerPoint, etc.).Working knowledge of ISO 13485 and 21 CFR Part 820.Knowledge of global regulatory and quality requirements associated with medical devices.Previous medical device (Class II or Class III) experience required (from product development, validation engineering, sustaining engineering or manufacturing engineering).Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred.Client is not able to provide H1B sponsorship right now but may be available in the future
Sr Director, Packaging Development & Project Management
Interparfums, Inc., New York
Part of the Interparfums group founded in 1982, Interparfums USA develops, manufactures and distributes prestige perfumes and cosmetics as the exclusive worldwide licensee for Abercrombie & Fitch, Anna Sui, DKNY, Donna Karan, Graff, GUESS, Hollister, MCM, Oscar de la Renta, Roberto Cavalli, Salvatore Ferragamo and Ungaro. Through its global distribution network, the Company's products are sold in over 120 countries.We are currently seeking a Senior Director, Packaging Development & Project Management to join our team in New York, NY. This role will report into the Chief Operations Officer. This position oversees the New Product Development (NPD) department in Operations, comprised of Packaging Development/Engineering & Sourcing and Project Management functions.This position is based in office from Mondays-Thursdays, and remote on Fridays.Key ResponsibilitiesEnsures new launches, value analysis, and redevelopment projects are managed on cost and on time while meeting company objectivesPresents monthly or as needed to top leadership CEO, COO, CMO regarding status for launches across all brands in portfolio. Responsible to escalate issues with recommended solutions and mitigation plan action for risks identifiedIdentifies and implements continuous process review and improvement projects within Packaging Engineer & Project Management departments, cross functionally, and with outside vendorsManages Global budget of tooling expenditure for new launches with COO and CEO approvalIdentification and implementation of value analysis, capacity, and overall brand health. Works with Sr. Director of Supply Chain to identify and respond to on-going business support needed to ensure right stock position across all brandsVendor relationships and portfolio managementResponsible for evaluation of vendor portfolio, management of the key vendor relationships, and evaluation of new vendors addedMaintenance of vendor relationships with Interparfums including contracts and planning, building innovation, and mitigating risksQuarterly and/or annual review process based on size of business with Supply Chain and Quality teamsNPD department leadership - ensuring the team is clear of company objectives, the department's path to achieve and proper resources are available to meet those objectivesResponsible for recommendation of sourcing and supply chain strategy within a global portfolio of vendors to the leadership teamOther duties as assignedEducation/ExperienceBA or BS degree from an accredited college/universityMinimum 12+ years in the fragrance industry with proven packaging development / engineering experienceMinimum 5+ years of people management experienceRequired SkillsTechnical competency, packaging development/engineering backgroundMust be able to adapt to change and integrate the changes into various moving parts to deliver a quality product in a timely manner.Leadership and Team management experienceExcellent communication skills, including written, verbal, and presentation; comfortable and credible with both internal and external partnersSelf-starter who will thrive in fast-paced, dynamic environmentPossess a strong sense of urgency and ability to multi-task and pivotWe OfferAn entrepreneurial career with a dynamic environment where all voices are heard and appreciatedLow hierarchy with high visibility to C-Suite on a regular basisA growing company with a proven track record of solid financial stabilityBonus opportunity based on personal and business performancePaid time off policies including vacation, holiday, and sick days401K plus company matchRobust healthcare, insurance, and benefit optionsOptions to support development, including complimentary access to LinkedIn LearningInterparfums USA, LLC is an equal opportunity employer and is committed to equal opportunity employment without regard to race, religion, color, sex, age, sexual orientation, national origin, citizenship, disability or any other basis of discrimination prohibited by applicable local, state or federal law.