Engineering Structures Jobs Salary Jobs in Hatfield
72 positions found
About Precis
Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.
Overview & Purpose:
Precis Engineering is seeking a Structural Engineer with 4 years or more of experience in hi-tech buildings and life-science building markets. This individual must have a strong engineering background and an understanding of building structural design and documentation from concept design through complete construction-issued documentation as well as experience in construction duration coordination with contractors.
The individual will be a structural design engineer for commercial, industrial, institutional and life science design projects working in design of cGMP spaces.Work will be conducted under the direction of the structural department director and act as the structural project lead coordinating with other discipline leads.
The individual will be resourceful and goal-oriented, desiring challenging work in a dynamic environment. The individual will be responsible for generating structural project deliverables such as conceptual, and construction issued design documents and corresponding narratives/reports.
Key Responsibilities
- Knowledge in design and documentation of structural design of multiple building materials such as steel, steel bar joists, metal deck, cast-in-place concrete, masonry, and wood.
- Possess knowledge of cGMP requirements as they relate to building systems is preferred.
- Develop new clients, maintain and expand the relationship and scope of work with existing clients.
- Knowledge in passive and active fall protection system selection is a plus
A successful candidate will have the following Qualifications
- Familiarity with MS Office products preferred.
- Experience with documentation software such as AutoCAD and Revit.
- Familiarity of finite element structural design software such as Risa-3D.
- Familiarity of structural design software like TEDDS and Hilti Profis
- Knowledge and competency with OSHA 29 CFR 1910 Subpart D Walking-Working Surfaces Regulations and ANSI Z359 is a plus.
Competencies
- Strong technical writing and communication skills
- Strategic Thinking/Problem Solving/Analysis
- Customer/Client Focus
- Communication Proficiency
- Represent the company in a positive and responsible manner
- Provide marketing, planning, scoping, and coordination of technical aspects of projects
- Time Management
Education / Licenses
BS degree in Civil (Structural) Engineering, and minimum EIT certified, PE Preferred
Why Join Precis?
- Be part of a collaborative, innovative team that values your ideas and expertise.
- Shape growth for a respected, specialized engineering and architecture firm.
- Enjoy a flexible, supportive work environment and competitive compensation package.
Equal Opportunity Employer
Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics
Founded and family?owned since 1896, Rhoads Industries is a total solution provider of industrial fabrication, mechanical/maintenance and maritime services. In addition to our field service and project skilled labor, Rhoads has expansive shipyard facilities and over 300,000 square feet of heavy manufacturing space located in The Navy Yard in Philadelphia. Rhoads capabilities enable our customers to achieve superior results by deploying our diverse, highly skilled workforce and fabrication capabilities across commercial, government and maritime projects, all backed by state?of?the?art resources and a 100+ year legacy of leadership.
As a member of the Rhoads team, youll join a quickly growing team of energetic, skilled tradespeople and professionals who are committed to delivering exceptional products and services to our customers across every market we serve. We are building on our success across more than a century by continuing to grow an innovative company dedicated to building exciting careers. Come join our journey, and experience what it means to be Done Right with Rhoads.
We are currently seeking experienced Structural Steel Fabricators to join our team. The Structural Steel Fabricator will be responsible for fabricating, assembling, and installing structural components and systems on ships and marine vessels. The ideal candidate will have a strong understanding of shipbuilding principles, be proficient in reading blueprints and technical drawings, and possess excellent welding and metalworking skills.
We are seeking candidates who are available to work 1st shift (M-TH, 6am-4:30pm) or 2nd shift (M-TH, 4pm 2:30am.) This role requires flexibility including weekends and overtime as business needs dictate.
What You Will Be Doing
- Interpret and analyze technical drawings, blueprints, and specifications to determine project requirements.
- Fabricate and assemble structural components, such as bulkheads, frames, and hull sections, using various metalworking techniques and equipment.
- Measure, cut, and shape metal components to precise specifications.
- Weld, braze, or solder metal parts together using appropriate techniques and equipment.
- Install and fit components and systems, including piping, ventilation ducts, and machinery supports, in accordance with project plans and specifications.
- Perform repairs and modifications to existing ship structures as needed.
- Inspect work pieces and finished products to ensure they meet quality standards and regulatory requirements.
- Follow safety protocols and guidelines to maintain a safe working environment.
- Collaborate with other tradespeople, engineers, and project managers to ensure efficient project execution.
- Maintain accurate records of work performed and materials used.
Your Background
- High school diploma or equivalent.
- Must be a US citizen.
- +5 years of proven experience as a ship fitter or similar metal working role (iron working, structural steel, etc.), within in a maritime or shipbuilding environment?
- Proficiency in reading and interpreting technical drawings, blueprints, and specifications.
- Strong welding and metalworking skills, including experience with various welding processes (e.g., arc welding, MIG welding, TIG welding).
- Familiarity with shipbuilding materials, tools, and equipment.
- Knowledge of shipbuilding principles and practices.
- Attention to detail and precision in workmanship.
- Ability to work independently and as part of a team.
- Good communication and interpersonal skills.
- Ability to work in a physically demanding environment and lift heavy objects.
- Vocational training or certification in metalworking, welding, or ship fitting.
- Previous experience in marine construction, ship repair, or shipbuilding.
- Knowledge of marine regulations and classification society standards.
- Familiarity with shipyard safety practices and procedures.
The Work Environment at Rhoads
- The performance of this position involves exposure to construction or industrial areas where the use of personal protective equipment such as safety glasses, hard hats and hearing protection is required.
What Rhoads Can Offer You
At Rhoads Industries, our team is the foundation of our success. Along with a competitive salary, we offer a variety of additional benefits designed to support your well-being and promote a healthy work-life balance for you and your family.
Benefits include:
- Competitive health insurance packages
- 401k matching
- PTO
Our Location
We are based out of The Navy Yard in Philadelphia, a reimagined industrial locale with more than 150 companies, 15,000+ people, 20 acres of parks, dining options, public art, and events throughout the year. Recognized as a leading model for repurposing military and industrial assets for a diversified modern economy, The Navy Yard has been dubbed the coolest shipyard in America.
For more information about Rhoads Industries and our opportunities please visit and follow us on LinkedIn. Rhoads Industries, Inc. is an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, and disability.
Overview & Purpose
Precis Engineering is seeking a mid-level Process Utilities Engineer with 5 years or more of experience focusing on the design and implementation of Clean Utility Systems (WFI generation and purified water systems) and Equipment Cleaning in Place (CIP) systems for the pharmaceutical, biotechnology, and/or chemical industries. This individual must have a strong engineering background and a thorough understanding of equipment design, CIP design, US Pharmacopia and BPE standards.
The individual will be resourceful and goal-oriented, desiring challenging work in a dynamic environment. Process is a young business endeavor for Precis and this individual will have an entrepreneurial and strategic mindset towards the long-term growth and viability of the group. He/she will be comfortable in a process execution role as well as representing the process discipline as a technical resource on larger, multi-discipline project teams. The individual will work be responsible for generating process-related project deliverables such as P&IDs, utility diversity calculations, user requirements, equipment specifications, piping design, and corresponding narratives/reports.
Responsibilities
- Responsible for execution and coordination of multi-discipline engineering teams for process projects comprised of Precis, client, and third-party personnel.
- Work in conjunction with a subject matter expert in design and implementation for process and clean utilities for pharmaceutical manufacturing clients.
- Experience with major clean utility and Cleaning equipment manufacturers.
- Prepare and review systems calculations, drawings, and specifications.
- Familiarity of instrumentation and automation and control approaches.
- Knowledge of cGMP requirements with respect to operations and manufacturing facility design.
- Ability to communicate and articulate process design deliverables and convey the project needs to complete construction drawing deliverables to clients and partners/
- Be able to manage work to a budget and schedule and report status to project oversight.
Qualifications
- B.S. in Chemical Engineering or related major required.
- Minimum of 5 years of experience in the field.
- The ability to work well with others, lead a team and manage in matrix teams and environments with multiple clients.
- Experience in process utility design and implementation.
- Experience in process deliverables such as Process Flow Diagrams, P&IDs, piping drawings and equipment specifications.
- Experience with AutoCAD and Revit drafting software.
- Delegation negotiating, and team skills.
- Effective presentation, written and verbal communication skills.
- Excellent organizational, planning, and time management skills.
- Logical thinking with creative problem solving skills.
- Understanding of budget control.
- Familiar with a variety of the field's concepts, practices, and procedures.
Competencies
- Process Engineering with a Focus on Process Utilities & CIP Equipment
- Specification of Process Equipment and Instrumentation
- Strategic Thinking/Problem Solving/Analysis
- Customer/Client Focus
- Communication Proficiency
- Time Management
Education / Licenses
- BS degree in Chemical Engineering or related
- Professional Engineer (PE) License, or FE Preferred
About Precis
Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.
Position Overview:
The Automation Engineer supports the Ambler, Pa., office with 3 years or more of experience in the design and implementation of industrial automation systems for the pharmaceutical + biotechnology, chemical, and/or building systems markets. This individual must have a strong engineering background and an understanding of instrumentation, control, and automation systems hardware and software design, testing, and implementation. Experience in Allen Bradley PLCs, Siemens Building Automation Systems, and/or the DeltaV DCS platform is preferred.
The individual will be resourceful and goal-oriented, desiring challenging work in a dynamic environment. The individual will be responsible for generating automation-related project deliverables such as P&IDs, loop sheets, control panel designs, instrument specifications, software specifications, testing protocols, and corresponding narratives and reports.
Key Responsibilities:
- Knowledge in design and implementation for process, utility, and building automation systems.
- Experience with major automation system vendors including Allen Bradley, Siemens, Honeywell, ABB, and Emerson.
- Familiarity of systems integration technologies and approaches.
- Experience in automation system implementation/migration projects and upgrades required.
- Knowledge of cGxP requirements as they relate to automation systems preferred.
- Present automation system designs at client meetings.
- Interface with third-party control system vendors.
- Develop new clients, maintain and expand the relationship and scope of work with existing clients.
Competencies
- Automation systems hardware and software
- Industrial and process instrumentation
- Strategic thinking, problem solving, and analysis
- Customer/client focus
- Communication proficiency
- Time management
Qualifications
- B.S. in Chemical, Electrical, or Mechanical Engineering or related major required.
- Minimum of 3 years of experience in the field.
- The ability to work well with others, lead a team, and manage in matrix teams and environments with multiple clients.
- Experience in automation systems design and implementation.
- Experience in industrial and process instrumentation types, technologies, and specification.
- Effective presentation, written, and verbal communication skills.
- Excellent organizational, planning, and time management skills.
- Logical thinking with creative problem-solving skills.
- Familiar with a variety of the field's concepts, practices, and procedures.
Why Join Precis?
- Be part of a collaborative, innovative team that values your ideas and expertise.
- Shape growth for a respected, specialized engineering and architecture firm.
- Enjoy a flexible, supportive work environment and competitive compensation package.
Equal Opportunity Employer
Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.
Metrology Specialist I
On-site in West Point PA
Summary:
- Manage equipment assets at multiple locations
- Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions
- Participate in computer system validation activities associated with new or upgraded equipment or software packages.
- Originate and progress Deviations and Change Control records
- Perform and document investigations and assist in developing and implementing CAPA plans
- Contribute to new SOP drafting, implementation, and revisions.
- Represent the laboratory on all aspects of laboratory equipment during audits.
- Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
- Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
- Willingness and ability to quickly upskill in Merck Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
- Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.
Calibration Focus:
- Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.
- Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
- Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.
Support the purchase, installation, and equipment qualification of new laboratory equipment.
*** There will be training opportunities to support Validation*** Validation activities are included below
- Support primarily the qualification/validation of computerized analytical systems as per current guidelines.
- Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers.
- Perform any required change control during the life cycle of a computerized system.
- Decommission systems as required as part of the equipment qualification/validation life cycle.
- Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.
- Participate in various data integrity and lab modernization activities as required.
- Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).
- Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.
General Requirements Level 1:
-Bachelor’s degree in biological or chemical science and/or engineering plus
-2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification
-Experience working in a GMP environment and maintaining laboratory equipment.
-Highly organized, strong communication skills.
-Capable of working independently.
-Solutions orientated mindset with the ability to handle multiple high priority tasks at one time.
-Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.
-Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment.
The Business Data Analyst will play a critical role in supporting data-driven decision-making for core PMA business functions. This position is focused on extracting valuable insights from complex datasets, creating operational reports, and developing intuitive BI dashboards tailored to business needs. Working within an enterprise reporting structure, the analyst will perform on-demand data discovery, conduct trend analysis, and develop analytics tools that empower stakeholders with meaningful insights. By ensuring data accuracy, quality and relevance, this role will support data governance activities and continuous process improvements that align with strategic objectives.
Responsibilities:
Data Analysis & Business Insights
* Conduct in-depth data analysis to support strategic business initiatives.
* Perform trend analysis and develop predictive insights to help business teams identify patterns, risks, and opportunities.
* Respond to data discovery requests and operational reports development to support key business metrics and decision-making.
* Deploy best practices and make recommendations for improved understanding.
* Translate complex data findings into actionable recommendations, presenting insights in a clear and meaningful way for non-technical stakeholders.
Enterprise Reporting & BI Dashboard Development
* Work closely with business stakeholders to understand their reporting needs, providing insights that drive data-informed decisions.
* Design, develop, and maintain interactive BI dashboards tailored to answering critical business questions, providing real-time access to critical metrics and performance insights.
* Utilize enterprise BI tools to create data visualizations that enable easy exploration of data and insights.
* Partner with stakeholders to test and refine dashboards, ensuring they align with business requirements and enhance decision-making capabilities.
* Facilitate training and support for business users on BI dashboards and reporting tools, enabling self-service access to data insights.
Data Quality Support & Validation
* Collaborate with data governance and data engineering teams to ensure high data quality and integrity in enterprise reports and dashboards.
* Perform data validation and verification as part of report development to ensure data accuracy, consistency, and relevance for business users.
* Monitor data accuracy metrics and support data issue resolution, maintaining a high standard of data quality across reporting tools.
* Demonstrate commitment to Company's Code of Business Conduct and Ethics, and apply knowledge of compliance policies and procedures, standards and laws applicable to job responsibilities in the performance of work.
Requirements:
* 3+ years of experience in data, analytics, or business intelligence.
* Bachelor's degree in Information Management, Data Science, Computer Science, Mathematics, Statistics, Economics, Psychology or a related field.
* Proficient in SQL for data extraction and manipulation across various data sources.
* Strong analytical skills to interpret complex datasets and draw actionable insights.
* Experience with BI platforms like QlikSense or Power BI for data visualization and dashboard development.
* Familiar with advanced Excel functions for data manipulation and reporting.
* Understanding of statistical methods and trend analysis for identifying patterns and creating projections.
* Familiar with predictive modeling or basic machine learning concepts is a plus.
* Proficiency with scripting languages or tools (such as Python, R, or VBA) for process automation is a plus.
* Basic understanding of data integration, ETL processes, and data warehousing concepts.
* Skilled in presenting data in a way that tells a compelling story and drives informed decision-making.
* Strong interpersonal skills to work effectively with cross-functional teams in underwriting, finance, and IT.
* High level of precision in data analysis, ensuring reports and insights are accurate and free of errors.
* Analytical mindset to investigate data challenges, identify root causes, and develop efficient solutions.
* Ability to adapt to evolving data requirements and troubleshoot issues with minimal supervision.
* Strong organizational skills to balance multiple projects and meet reporting deadlines.
* Effective time management to handle ad hoc requests and prioritize tasks in a fast-paced environment.
* Open and motivated to learn new tools, methods, and data practices.
Founded and family?owned since 1896, Rhoads Industries is a total solution provider of industrial fabrication, mechanical/maintenance and maritime services. In addition to our field service and project skilled labor, Rhoads has expansive shipyard facilities and over 300,000 square feet of heavy manufacturing space located in The Navy Yard in Philadelphia. Rhoads capabilities enable our customers to achieve superior results by deploying our diverse, highly skilled workforce and fabrication capabilities across commercial, government and maritime projects, all backed by state?of?the?art resources and a 100+ year legacy of leadership.
As a member of the Rhoads team, youll join a quickly growing team of energetic, skilled tradespeople and professionals who are committed to delivering exceptional products and services to our customers across every market we serve. We are building on our success across more than a century by continuing to grow an innovative company dedicated to building exciting careers. Come join our journey, and experience what it means to be Done Right with Rhoads.
The Operations Supervisor is responsible for overseeing daily operations within the manufacturing or industrial facility, ensuring that production goals are met efficiently, safely, and within quality standards. This role involves managing a team of workers, coordinating activities across departments, and implementing process improvements to optimize productivity and operational effectiveness. The Operations Supervisor plays a key role in maintaining a safe work environment, adhering to company policies, and driving continuous improvement initiatives. This is a non-union role.
The Operations Supervisor role requires flexibility in working hours including nights, weekends, and overtime as business needs dictate.
What You Will Be Doing
Operational Oversight:
- Monitor daily operations to ensure that processes are executed efficiently and in compliance with company policies and industry regulations.
- Implement and enforce safety protocols and procedures to maintain a safe working environment.
- Oversee parts and component management to streamline and support Operations and Production activities
Quality Control:
- Ensure that products or services meet quality standards and specifications.
- Address and resolve quality issues or defects promptly.
- Conduct regular inspections and audits to ensure compliance with quality control standards.
Staff Management:
- Supervise and lead a team of employees, including scheduling, training, and performance management.
- Conduct regular performance reviews and provide feedback to staff to ensure productivity and adherence to company standards.
- Resolve employee conflicts and address any issues related to job performance.
Process Improvement:
- Identify areas for improvement within operations and recommend changes to enhance efficiency and effectiveness.
- Analyze operational data to assess performance and identify trends or issues.
- Implement best practices and standard operating procedures (SOPs) to streamline operations.
Reporting and Documentation:
- Prepare and submit regular reports on operational performance, including production metrics, safety incidents, and staffing levels.
- Maintain accurate records and documentation related to operations, inventory, and personnel.
Customer Service:
- Address customer complaints or concerns related to operational issues and work to resolve them in a timely manner.
- Ensure that customer satisfaction is maintained through effective service delivery.
Compliance and Safety:
- Ensure compliance with all relevant laws, regulations, and industry standards.
- Conduct safety training sessions and ensure that all staff adhere to safety protocols and procedures.
Your Background
- High School/GED preferred. Education and/or training (i.e. Technical School, Apprenticeship, degree in any engineering discipline) preferred.
- 1+ years of proven experience in a Group Leader, Foreman, General Foreman, or similar crew leadership role required.
- Previous supervisory experience in a structural shipyard or construction environment. Experience supervising in Ship fitting, Welding, and/or Fabrication environments highly preferred.
- Must be willing to work flexible hours, including nights, weekends, and overtime as business needs dictate.
- Within 90 days, must be able to pass operations supervisor training courses and skills tests.
- Must possess strong PC skills including proficiency with Microsoft Office Suite.
- Relevant certifications (i.e. Lean Manufacturing, Six Sigma, OSHA 10/30) are a plus.
- Proven track record of managing teams and executing operational processes.
- Experience with production planning, quality control, and safety management.
- Strong leadership and management abilities.
- Excellent problem-solving and decision-making skills.
- Solid understanding of quality control standards and safety regulations.
- Ability to analyze data and generate actionable insights.
- Proficiency in blueprint and drawing interpretation.
- Good organizational, presentation and communication skills.
- Ability to interact with various levels of customers and subcontractors.
- Ability to work independently as well as to function effectively and collaboratively in a team environment.
- Excellent time management and organizational skills; detail oriented and efficient.
- Ability to handle multiple tasks and responsibilities in a rapidly growing organization; experience managing personnel.
- Ability to communicate requirements in an industrial environment, and to give effective direction by using written and/or verbal skills where appropriate.
The Work Environment at Rhoads
- The performance of this position involves exposure to construction or industrial areas where the use of personal protective equipment such as safety glasses, hard hats and hearing protection is required.
- Must be able to work in a variety of physical positions, including sitting, standing, walking, and driving in an automobile
- Will require walking and standing on irregular, uneven surfaces in an industrial setting and possibly at increased heights climbing and descending ladders, ship stairways, and confined spaces.
What Rhoads Can Offer You
At Rhoads Industries, our team is the foundation of our success. Along with a competitive salary, we offer a variety of additional benefits designed to support your well-being and promote a healthy work-life balance for you and your family.
Benefits include:
- Competitive health insurance packages
- 401k matching
- PTO
- Paid holidays and annual leave
Our Location
We are based out of The Navy Yard in Philadelphia, a reimagined industrial locale with more than 150 companies, 15,000+ people, 20 acres of parks, dining options, public art, and events throughout the year. Recognized as a leading model for repurposing military and industrial assets for a diversified modern economy, The Navy Yard has been dubbed the coolest shipyard in America.
For more information about Rhoads Industries and our opportunities please visit and follow us on LinkedIn.
Rhoads Industries, Inc. is an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, and disability.
Mechanical Engineer -
At Wesco Industrial Products, we are looking to hire a person who is results-driven, has the desire to excel, works with high energy, has a positive approach, is flexible, detail-oriented, and can handle a large volume of projects. Our Mechanical Engineer designs, develops, and improves new and existing products, components and fabrications, tests prototypes while ensuring product integrity and technical accuracy, and applicability. This position also releases final product for manufacture and distribution. We are looking for a local candidate to work onsite at our North Wales, PA facility.
What you will be doing:
- Manage projects, changes, and/or development from start through completion.
- Plans, designs, and develops products and components for projects assigned.
- Analyzes research data and proposed product specifications.
- Ensure the highest quality standards and lowest cost levels are met.
- Uses Solid Words to engineer products.
- Creates and updates bills of materials using CAD and ERP systems.
- Consults with suppliers in relation to parts or products necessary to design or improve products and components.
- Provides design, prototype, and validation support for improving existing products.
- Oversees manufacturing of products.
- Creates and updates product documentation.
- Visits suppliers looking for advances in new technology.
- Monitors and analyzes the technology markets to identify and understand new product opportunities.
What are we looking for?
- Bachelor’s degree in mechanical engineering, mechanical design, or a related field.
- 5-7+ years of engineering experience, preferably in product design engineering duties with a strong work background within a manufacturing environment.
- Experience with CAD standards.
- Experience in product design, GD&T using Solid Works, Inventor, FEA, and DFMEA.
- Significant “hands on the product” type experience.
- Working knowledge of and ability to use 3D and 2D CAD.
- General Understanding and experience using business ERP systems and software.
If you are interested in working for a top-notch employer with an outstanding wage and benefit plan, this is the position for you. For more information on 4Front Engineered Solutions, please visit our website at you are interested or know someone who may be interested in working for a premier employer or want more information, please contact John Vandenberg at or 262-496-5374.
JOB OVERVIEW:
The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.
KEY ROLES/RESPONSIBILITIES:
- Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
- Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
- Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
- Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
- Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
- Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
- Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
- Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
- Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
- Represent Technical Services at project team meetings and provide sound technical advice.
- Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
- Directly interact with Piramal Pharma Solutions clients.
- Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.
EXPERIENCE:
- Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
- Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
- Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
- Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
- Technical writing experience is required with attention to detail skills essential.
- Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
- Must have proficiency in the Microsoft Office Suite programs.
- Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
- Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
- Must be innovative, proactive, resourceful and committed to continuous improvement.
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.
WORK ENVIRONMENT:
The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.
12 months
West Point, PA, USA, 19486
Description:
Qualifications:
*B.S./M.S. degree in appropriate engineering/scientific field
*Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry
*Previous experience in writing investigations for atypical events in a manufacturing environment
*Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
*Demonstrated ability to work both independently and as a part of a cross-functional team
*Excellent written and verbal communication skills
Responsibilities:
*Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
*This individual will be responsible for providing scientific support for manufacturing areas within Manufacturing Division
*This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations
*Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required
*Analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments is required
*Off-shift work may be required