Project Engineer jobs in United States, Pennsylvania, Longswamp Township

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

The Project Specialist, Metrology is responsible for managing the West Services and Solutions (WSS) CAPEX program from planning and initiation through asset registration and implementation. You will be responsible for identifying and aligning stakeholders from cross-functional teams, creating, maintaining, and reporting project schedules, forecasting, updating, and reporting on financials associated with each project, and coordinating the WSS CAPEX items within the overall Global Quality Laboratory CAPEX budget. Responsible for driving projects to completion based on timelines, budget, and resources.

• Create and maintain the yearly WSS CAPEX program schedule for all items approved for the CAPEX budget
• Hold regular project meetings with cross-functional stakeholdersCreate and maintain detailed project schedules (Gantt or similar)
• Facilitate alignment of timelines, responsibilities, and deliverables in accordance with procedures
• Follow escalation procedure for delayed/impacted projects and Track project milestones
• Report project status highlighting risks and opportunities for improvement
• Track and report financials associated with each CAPEX project
• Coordinate with WSS Lab Purchasing, WSS Metrology, Global Technical Projects, Global Finance, and Quality Laboratory to establish and provide accurate
  • forecasting and closure of projects
  • Track and report budget adherence
  • Manage resource allocation and communication for the program
• Ensure appropriate resources have been committed to each project working with management when there are conflicts
• Maintain a clear and unambiguous communication plan with all stakeholders and management for expectations, commitments, timelines, deliverables, responsibilities, and status
• Proactively identify and facilitate resolution of all project-related issues
• Management/initiation of associated administrative details: initiating change controls assigning tasks, resources, and timelines, requesting the initiation of required documents, general administrative tasks to keep the projects on track
• Implement change management processes, when needed, to align with shifting requirements and priorities
• Support the WSS Metrology team with routine tasks, as needed

• Bachelor's Degree in a related area or equivalent experience
• Minimum 2 years of experience in metrology/analytical instrumentation in a cGMP environment, preferred
• Minimum 2 years of experience in project management, preferred

• Demonstrated ability to multi-task and manage multiple projects simultaneously
• Strong understanding of a cGMP environment
• Experience with Quality Management Systems
• Dependable, highly organized, detail oriented, able to think creatively under pressure and work in a fast-paced, constantly changing environment
• Excellent written and verbal communication skills
• Familiarity with SAP
• Experience with project management tools such as MS Project
• Able to comply with the company’s safety and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities

• Project Management Certificate, such as CAPM, preferred

The HRIS Project Specialist has responsibility for supporting the delivery and execution of West’s HR Projects.

Portfolio Management

• Drive transparency of project workloads, commitments and expectations by managing reporting and dashboards out of the West Project Management system.
• Champion of the HR PMO processes and the agile methodology.
• Support departments with the setup and maintenance of projects within the West Project Management system.
• Build and maintain strong relationships with customers, business partners, resource managers, and other senior level executives.

Project Management

• Manage smaller projects as assigned by the HR PMO.
• Maintain the project related data and documents within the West Project Management System.
• Define, drive and manage change management and communications activities that support assigned projects.

Harmonization

• Work closely with HR leaders and stakeholders to standardize HR processes globally.
• Drive harmonization of different approaches across global locations
• Develop strategies to ensure consistency and efficiency in HR operations.

Training and Support

• Develop training materials and provide support to teams during process implementation.
• Ensure that team members understand and adhere to new processes.

Other duties as assigned.

• Bachelor's degree in Human Resources, Business Administration, or a related field or equivalent experience
• 3-5 years experience in Project Management, preferably in HR operations.

• Excellent analytical and problem-solving skills.
• Ability to work independently and collaboratively in a global, multicultural environment.
• Exceptional communication and interpersonal skills, with the ability to communicate effectively with colleagues across the company from SME to Management teams
• Self-motivated and dynamic individual who is able to challenge and influence others, develop and maintain collaborative working relations across HR and other functions at West
• Familiarity with HRIS (Human Resources Information System) platforms.
• Project management skills with the ability to manage multiple tasks and priorities.
• Proven experience in managing projects related to HR process improvement.
• Familiarity with Agile or other project management methodologies.
• Experience coordinating and leading cross-functional project teams.
• Ability to comply with the company’s safety and quality policy at all times.

• Must be able to travel up to 10% of the time

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

· Perform physical testing of drug delivery devices (e.g., injection force, injection time, dose accuracy) using lab equipment such as Instron or Zwick systems.

· Set up, execute, and document testing activities in accordance with protocols and Good Documentation Practices (GDP).

· Support the development, verification, and validation of test methods under the guidance of senior engineers.

· Assist in the evaluation of device components (e.g., stoppers, barrels, springs) for fit, function, and quality.

· Participate in basic root cause investigations of product or test method deviations.

· Contribute to technical reports, data summaries, and documentation for design verification and regulatory submissions.

· Collaborate with cross-functional teams including QA, Regulatory, and Manufacturing to support development activities.

· Learn and apply relevant quality and regulatory standards (e.g., ISO 13485, ISO 14971, 21 CFR Part 820) in daily work.

Required Qualifications

· BS in Mechanical Engineering, Biomedical Engineering or a related field

· 0-2 years Medical Device or Combination Product experience

· Strong academic foundation in engineering principles and an interest in medical device or drug delivery systems including a good foundation in solid mechanics, mechanical design and fluid dynamics..

· Some hands-on lab experience (academic, co-op, or internship) with physical testing or mechanical systems.

· Ability to follow protocols and standard operating procedures.

· Effective written and verbal communication skills.

· Eagerness to learn in a collaborative and regulated environment.

Preferred Qualifications:

· Internship or cooperative experience in the pharmaceutical, biotech, or medical device industry.

· Exposure to regulated environments or quality systems (e.g., ISO 13485, GMP).

· Familiarity with Microsoft Excel, basic statistical tools, or mechanical test instruments.

· Experience in mathematical modeling and finite element analysis

· Experience in statistical analysis for medical devices

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays
• Life and Disability Protection: Company paid Life and Disability insurance
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

The Validation Engineer I role is responsible for assisting in the timely development, execution and approval of all validation programs and lifecycle documentation, e.g. SOPs, Change Controls, CAPAs, Deviations, ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices.

This role will execute validation activities to ensure completion of projects per schedule requirements

The selected individual will be a key member of the R&D organization that owns and operates several cGxP laboratories and a manufacturing facility located at the West Chester campus.

Essential Duties & Responsibilities:

• Support all aspects of the Validation Life Cycle from design through operation and retirement.
• Responsible for authoring and execution of site Validation documentation (i.e. qualification protocols, summary reports, risk assessments, and periodic reviews)
• Perform temperature mapping studies for controlled temperature units (refrigerators, freezers, stability chambers, and walk-ins)
• Ensure vendor protocols are complete and accurate, assist vendor with issue resolution and validation deviation reporting
• Support revalidation program
• Represent Validation in multi-disciplinary teams focused on production and laboratory equipment and activities (i.e. commissioning, validation, and computerized system validation)
• Create and update Validation standard operating procedures
• Contribute to site alignment with corporate standards and cGMP guidelines
• Technically independent and maintains up-to-date knowledge of Validation standards and regulatory compliance requirements
• Work with subject matter experts to implement and/optimize key validation and quality initiatives at Teva Biologics
• Work with QA/Manufacturing group members to initiate Deviations and implement corrective and preventive actions
• Support internal and external audits and assessments
• Support continuous improvement projects and activities
• Ensure training is up to date

• BS or equivalent combination of education and experience in life science or engineering

PREFERRED QUALIFICATIONS:

• Knowledge of validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines)
• Validation experience with production equipment, support equipment, HVAC and other utilities, analytical lab equipment, computerized systems/automation, CIP, and cleaning verification
• Cooperative, independent, critical thinking, multi-tasking and detail oriented
• Excellent oral and written communication skills
• Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.