Engineering Jobs in Kulpsville Pennsylvania
45 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.
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.
Maintenance Manager
$100,000 - $120,000 + 10% Bonus (OTE: $110k - $132k) + Great PTO + Holiday + Company Laptop + Company Phone + 401K + Medical + Dental + Vision + Life Insurance + Other Excellent Benefits.
Telford, PA (Commutable from: Landsdale, Doylestown, Norristown, King of Prussia, Quakertown, Pottstown, Collegeville, Phoenixville, Allentown, Bethlehem).
Are you a Maintenance or Engineering leader who wants more autonomy, real influence, and the chance to build something your way?
This is a role where you can step in, take ownership of the maintenance function, and genuinely shape the future performance, culture, and direction of the site, whilst progressing your career toward senior operations or engineering leadership.
Now is an excellent time to join this industry leading organization at a state-of-the-art facility, recognised for exceptional quality, operational excellence, and commitment to long-term career growth.
In this high-impact leadership role, your experience in moving towards a proactive maintenance approach will be key to improving site performance. You will lead and develop a skilled team, implement preventative and predictive maintenance programs, and utilise CMMS systems to improve planning, performance, and cost control.
This role would suit someone with maintenance or engineering leadership experience from manufacturing, production, FMCG, packaging, or a similar industrial environment, looking to step into a role with real autonomy and long-term progression.
The Role:
- Lead site-wide maintenance strategy across mechanical and electrical systems.
- Improve equipment reliability, reduce downtime, and enhance team performance.
- Oversee maintenance planning, CMMS, and inventory management.
The Candidate:
- Previous maintenance leadership within a manufacturing environment.
- Technical knowledge Mechanical and Electrical systems.
- Ability to drive improvements, lead teams, and implement proactive maintenance strategies.
To apply for this role or to be considered for further roles, please click "Apply Now" or contact Oliver George at Rise Technical Recruitment.
Rise Technical Recruitment Ltd acts an employment agency for permanent roles and an employment business for temporary roles.
The salary advertised is the bracket available for this position. The actual salary paid will be dependent on your level of experience, qualifications and skill set. We are an equal opportunities employer and welcome applications from all suitable candidates.
Maintenance Manager, Maintenance Supervisor, Maintenance Leader, Plant Manager, Plant Supervisor, Plant Engineer, Service Manager, Service Supervisor, Service Leader, Production Manager, Production Supervisor, Production Leader, Maintenance, Service, Repair, Installation, Troubleshooting, Management, CMMS, Controls, PLCs, Electrical, Mechanical, Predictive Maintenance, Preventative Maintenance, Proactive Maintenance, Leadership, Packaging, Labeling, Industrial Manufacturing, Industrial Machinery Manufacturing, Manufacturing, Telford, Pennsylvania.
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.
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
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.
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.
The Buyer/Planner coordinates activities involved with planning and procuring goods and services for multiple product lines. They are responsible for planning and purchasing items such as electromechanical assemblies, fabricated parts, and electronics. They understand different manufacturing processes and have a willingness to travel both domestically and internationally. Work closely with Engineering, Accounting, Scheduling, Receiving and Production personnel to ensure timely delivery of materials while following appropriate policies and procedures. This is a hybrid role requiring at least three days in our office in Eagleville, PA.
Essential Duties and Responsibilities:
- Issue requests for quotes (RFQ) and select the best source consistent with cost, quality and delivery requirements. Negotiate and manage long-term pricing agreements on critical commodities.
- Complete purchase requests with domestic and international suppliers by inputting purchase orders, expediting deliveries, and verifying all transactions.
- Handle correspondence concerning over-shipments, delivery shortages, changes in quantity, delivery dates, and prices and report such changes to the interested parties in a timely manner as required.
- Act as a liaison between suppliers and involved departments to resolve procurement-related problems.
- Source new products to meet new product launch timelines.
- Authorize payment for purchases by reviewing invoices and related documentation.
- Maintain appropriate inventory levels consistent with inventory goals and as set by management.
- Maintain accuracy of system information, including lead-time, pricing, current supplier information, current purchase order data, etc.
- Monitor supplier performance by ensuring that product is delivered as scheduled and meets specifications; maintaining appropriate files and records of meetings with suppliers to ensure company requirements are met and that the supplier is aware of their performance.
- Contribute to team effort by accomplishing other job-related tasks as needed, enabling other workers to achieve their job objectives.
- Source new suppliers as required and determine the best source of supply by evaluating price, quality, manufacturing capabilities, lead time, service support, and financial stability.
- Participates effectively as a member of a team promoting the exchange of ideas, information, and feedback in all directions.
- May work directly in support of line operations and in collaboration with department managers, engineers, or operations staff.
- Demonstrate leadership and expertise in Lean Manufacturing.
Knowledge, Skills, Experience and Education requirements:
- Professional purchasing in manufacturing or related industry.
- Bachelor's degree (BS/BA) and 5 years' experience.
- Must understand an MRP software system.
- Knowledge of the electronic component industry.
- Working knowledge of Excel, Word, and PowerPoint.
- Experience in negotiation.
- Ability to perform in a fast-paced, deadline-oriented work environment.
- Ability to work well with others in a team environment.
- Excellent organizational, written, and verbal communication skills.
- Preferred to have experience with international travel.
**This is a hybrid role - qualified candidates must be available to come in to our office in Eagleville, PA at least three days per week.
Design and Mechanical Engineer – Medical Devices
Join a global leader medical device company. Design and manufacture technology used in spine and orthopedic surgeries
You will work on the design and development of surgical implants and instruments, collaborating with engineers, surgeons, and cross-functional teams to bring innovative products to market.
Full‐time | W2 | M-F 8am- 5pm | On site Audubon PA (outside of Philadelphia)
Qualifications
- 4+ years of mechanical and medical device design engineering experience.
- II and III medical device experience
- Experience with CREO or SolidWorks for mechanical design and documentation.
- Experience working within regulated environments (ISO 13485 / FDA).
- Ability to work in both engineering and clinical environments, including operating rooms and labs
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or related field.
Benefits:
Visa sponsorship supported within US
W2 contract
Audubon, PA (outside Philadelphia)
Bonus for relocation within US and annual bonuses
Work directly with surgeons
Full product development lifecycle exposure
Key Responsibilities
Product Development
- Lead the design and development of surgical instruments and implants using CAD software (CREO).
- Develop and maintain project plans and FDA-compliant Design History Files (DHF).
- Perform design verification and validation to ensure designs meet technical specifications.
- Manage assigned projects to ensure timely completion while maintaining compliance with regulatory requirements.
- Collaborate with internal prototype teams and external vendors for rapid prototyping and testing.
- Support preparation of regulatory submissions to the FDA.
Customer Engagement
- Work directly with surgeons and clinical users to gather product feedback and translate clinical needs into design requirements.
- Participate in product launches, sales training, and customer visits.
- Support surgical cases in the operating room to observe device performance and identify opportunities for improvement.
Cross-Functional Collaboration
- Partner with marketing and product management to develop market strategies and forecasts.
- Collaborate with operations and manufacturing to support production and commercialization.
- Conduct competitive and industry research to ensure innovative product development.
Product Lifecycle & Sustaining
- Support the lifecycle management of commercialized products.
- Drive design improvements, cost reduction initiatives, and engineering changes.
- Work closely with Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure product performance and compliance.
The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,
Apply, and please feel free to reach out.
Senior Scientist
Kelly Science and Clinical, is currently seeking a Senior Scientist (Protein Mass Spectrometry) for a long-term engagement at one of our Global pharma clients in Spring House, PA. This role is a fully benefitted position. This role you will be eligible for Medical, Dental, 401K, paid time off, including holiday, vacation and sick/personal time.
Schedule: On-site Monday through Friday 8am to 5pm
Length of assignment: Until the end of 2026 will likely to extend
Pay: $45-50 an hour Depending on experience
You will be required to provide your own laptop
- Responsibilities:Intact protein mass analysis using LC/MS platforms- QC analysis and high throughput analysis for biologics (mAbs, multispecifics antibodies, Fabs, scFv, fusion proteins)
- Data analysis, documentation, and reporting – ELNs, etc.
- Lab instrument maintenance – General ESI source cleaning and routine calibration
- Prepare HPLC solvents and replenish as needed
- Prepare general buffers and reagents for enzymatic digestions and assays etc
- MS Lab-specific supply maintenance – inventory and ordering
- Chemical inventory for EHS
- Additional Duties:
- Support assay development and validation as needed.
- Assist in drafting and executing peer-reviewed posters, manuscripts, tech reports, and patent filings.
- Attend in-house seminars to support team goals.
- Requirements: Experience with mass spectrometry is required.
- Previous experience handling and working with proteins using general protein biochemistry techniques including but not limited to aliquoting and pipetting is required.
- Pharmaceutical experience working with antibodies is preferred.
- Experience with automated liquid handlers is preferred. Pharmaceutical experience working with antibodies is preferred.
- Candidate must be highly organized, independent, and very detail oriented.
- Education requirements: Ph.D. with 0-2 years’ experience, or MS with 3-5 years’ experience, or a B.S. with 10+ years in an analytical chemistry discipline
What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
#P1
12 motnhs
Remote opportunity.
Work location: WestPoint, PA is an option for candidate who are local and want to work from office(hybrid).
Summary
We are seeking a technical writer who will author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts.
* The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
* The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
Primary Responsibilities:
* Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
* Authoring and reviewing documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review.
* Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
* Collaborate closely with key stakeholders.
Education:
* Minimum qualification- BS/BA in life sciences/engineering is required
* Master's degree/PHD preferred
Required Experience and Skills:
* At least 2 years working experience in a cGMP laboratory environment.
* Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control.
* Strong oral and written communication skills.
* Work independently and within cross-functional teams.
* Maintain a proactive and service-oriented mindset.
* Experience with MS Office and document repository systems.
Preferred Experience and Skills:
* Experience with analytical method validation and transfer according to ICH and USP guidelines.
* Experience with laboratory data management systems
Software skills: MS office suite
Personality:
* Detail oriented
* Excellent writing skills
* Collaborative
* Good communication and interpersonal skills.