דרושים Sr Engineer R&d Integrated Systems ב-West Pharma ב-United States, West Whiteland Township

The incumbent will be a strong advocate of quality systems and quality culture with the drive, experience and knowledge to be able to provide mentorship and direction on best practices.

The position can be located at any West site and is not limited to Exton.

• Ensure success of assigned projects by overseeing all aspects of project planning, resourcing, communications, problem solving etc.
• Coordinate Quality Culture events and initiatives such as Quality Culture workshops, recognition programs, customer visits etc.
• Establish and lead cross-functional quality-related meetings to review and discuss performance, status and prompting necessary actions as required.
• Partner with L&D, HR and other relevant functions to drive improvements to employee onboarding and training.
• Partner and/or liaison with other West functional areas to drive optimization of processes and procedures and bring resolution to issues.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Report out on projects and initiatives to Executive and Senior Leadership as requested.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• All other duties as required.

• Bachelor's Degree or equivalent experience required
• Master's Degree preferred

• Minimum 8 years Quality or related experience required
• Experience in regulated industry such as pharmaceutical and medical device preferred
• Experience with SAP and MasterControl systems preferred

• Project Management skills, able to manage multiple projects across the globe
• Ability to to forsee potential problems and navigate challenges efficiently all while maintaining a strong focus on stakeholder requirements and project goals.
• Strong interpersonal skills and ability to communicate at all levels of the organization e.g. during Global townhalls etc.
• Ability to work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions
• Knowledge of cGMP, cGDP, relevant ISO standards and medical device/Pharma requirements
• Ability to adhere to all company safety and quality policies

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

• Use technical expertise to identify system, network, and application vulnerabilities, adjusting designs based on new threat data.
• Collaborate with Infrastructure and Application teams for security reviews, vulnerability assessments, and remediation.
Support the implementation of Next Generation WAN/LAN architecture across the enterprise.Configure, implement, document, and manage security tools including Network Security, Cloud Security, End-Point Security, SIEM, DLP, Email, and security awareness training.
• Conduct automated/manual vulnerability assessments and penetration testing, collaborating with teams on remediation.
• Work closely with SOC/NOC to meet performance indicators and mitigate threats/vulnerabilities, including Security Incident & Event Management and daily threat analysis.
• Monitor systems to enhance network performance.
Troubleshoot, resolve, and communicate networking issues to employees and management.Assist with disaster recovery procedures and test plans.Diagnose and resolve hardware, software, and other network/system issues, replacing faulty hardware as needed.
• Provide system support and maintenance per standards, Network and Cybersecurity Service Delivery model, West policies, procedures, and regulatory requirements.
• Help create and maintain system lifecycle documents including Policies, SOPs, and SOIs per West policies and procedures.

• Bachelor’s degree, Diploma or equivalent experience

• 8-15 years of relevant experience

Proficiency with security products such as firewalls, URL filtering, and virus protection.Deep understanding of network infrastructure and security, including SD-WAN, routing, firewalls, and cloud networking.
• Strong focus on providing cost-effective security solutions while staying updated on security threats.
• Exceptional communication skills to translate IT concepts for non-technical audiences.
• Experience with Linux/Windows operating systems, coding languages, and networking basics like switches and routers.
Familiarity with Microsoft Azure, Cisco Networking, Fortinet SD-WAN, and security tools like IDS/IPS and encryption.
• Ability to work globally in a virtual environment, managing multiple priorities with flexibility.
• Proactive work ethic, effective prioritization in high-pressure situations, and adherence to relevant company SOPs.

• Develop strong, cross-functional relationships within West Pharmaceutical’s Integrated Systems Operating Unit to establish the FP&A team as a key strategic partner in decision making.
• Analyze month-end financial results, working closely with the accounting team to ensure accuracy and integrity of financial reporting and resolve any discrepancies.
• Collaborate with the Integrated Systems Unit leader and leadership team to support and guide short-term and long-range planning with comprehensive financial analysis and insights.
• Lead the execution of budget, forecast, and strategic plan models, ensuring precision and alignment throughout monthly, quarterly, and annual processes. Conduct variance analysis to aid in performance evaluation.
• Review and influence strategic investments through comprehensive analysis of capital project business cases and Project Expenditure Request (PER) models, ensuring alignment with business objectives.
• Ensure financial planning aligns with organizational goals by identifying key financial drivers, evaluating risks, and providing actionable insights to support informed decision-making.

• Bachelor's Degree in Finance or Accounting required
• MBA, CPA/CFA strongly preferred

• 10+ years supporting the budgeting, forecasting, and long-term planning for a global, publicly traded business

• Manufacturing industry experience
• Excellent technical and analytical skills in finance, forecasting, financial analysis, and budgeting.
• Understanding of business disciplines to develop, analyze and interpret financial data.
• Executive presence and experience presenting to senior leadership.
• Demonstrated ability to work in a team environment on a global basis.
• Strong influencing and change management skills.
• Present analyses and advocate recommended actions to a variety of audiences with self-confidence.
• Ability to multi-task, prioritize tasks, and drive projects to completion with tight timelines.
• Demonstrated ability to learn quickly when facing problems and ability to apply knowledge to new situations.
• Superior verbal, written and interpersonal communication skills.
• Ability to interact with all levels of the organization, including Executive leadership.
• Strong work ethic and integrity to handle confidential/sensitive information.
• Ability to make recommendations and decisions independently.
• Experience using tools and systems such as SAP HANA, Hyperion, PowerBI, SAP BI, Microsoft Office products etc.
• Ability to lead teams and build effective working relationships both internally and externally.
• Strong presentation, communication, and interpersonal skills.
• Self-starter and results oriented independent worker.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Ability to comply with the company’s safety and quality policy at all times.

• Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Organizational skills will enable planning, prioritization and 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

The Sr. Associate – Technical Sales is primarily responsible for the identification and qualification of new opportunities and leads to support the launch of Integrated Systems. Strong research and analytical skill sets will be utilized to conduct targeted market research and associated analysis to identify new potential customers and emerging trends. The role requires establishing new customers to West and driving value via understanding the customer pipeline and aligning the appropriate Integrated System product. Develop additional strategy to continue to expand the West reach with new accounts as well as continued enhancements or development of new processes to drive efficiency with all service models. The Sr. Associate – Technical Sales is a self-starter who possesses a natural ability to proactively chase new avenues for identifying and capturing new accounts to the West Integrated System portfolio as well as working with Business Development and Strategic Marketing on top of the funnel tactics. This person will quickly develop their ability to identify, manage, and grow new and existing business.

• Responsible for the Integrated Systems Platform sales, engaging with both customers and internal teams to drive strategic growth initiatives.
• Acquire and manage new business through prospecting conversion of leads with a focus on our Integrated Systems portfolio.
• Develop strategies to forge new relationships with prospective customers by uncovering opportunities through strong listening and interviewing skills, understanding their drug pipeline, and offering tailored solutions that align with their needs.
• Provide support for effective customer follow-up from webinars and other West events, and engage with customers through the leads process, collaborating with Marketing on product campaigns tailored to our customer portfolio.
• Perform data analytics for customer or platform portfolios to drive enhancements to product and service models in support of new accounts and how they will be appropriately serviced.
• Understand market trends including relevant competitors, technology and regulatory issues to keep customer informed
• Utilize all service platforms, manage customers, training of the customers, and optimizing the use of support systems as well as working with other departments to improve the overall service model to these new account

Bachelor’s degree in Bioscience, Biochemical. Chemistry, Engineering, Pharmaceutical or equivalent experience. MBA preferred

Minimum 5 years of relevant B2B technical sales experience in industries that require a high degree of technical knowledge and regulatory requirements

• Knowledge or experience with ERP tools like SAP with Sales and Distribution
• Experience in prefilled syringe products and/or services.
• Exhibit strong competency in sales process and strategic account planning by regularly achieving business results that accurately mirror or exceed forecast
• Ability to strategically prioritize and suitably adapt and improve on strategic approach as and when necessary to focus on high value and likely to win opportunities/accounts
• Demonstrates knowledge of market segment, trends and internal customer issues that may influence a customer's priorities, tactics, and business approaches. Remains current on competitors, new technology and regulatory issues to maintain West’s scientific leadership position in the market
• Anticipates risks and devises contingency plans to meet them. Understands situation from many perspectives and makes decisions accordingly.
• Resourceful and is comfortable in navigating through internal resources by collaborating cross-functionally and can utilize resources effectively.
• Working knowledge of MS Office
• Familiarity with CRM systems is a plus
• Previous experience with cold calls and/or developing strategies to connect with and onboard new customers is strongly preferred
• Natural ability to demonstrate creativity with innovative thinking to discover and implement enhancements to existing processes
• Customer-Focused Attitude: A customer-centric approach with a genuine desire to ensure customer satisfaction and build lasting relationships
  Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Self-Starter with ability to work independently in a global environment as well as in team settings for project and/or process specific needs
• Be aware of all relevant SOPs as per Company policy as they relate to the role covered by this Job Description.
• Fully compliant with the company’s safety and quality policies at all times.

• Work is performed in an office environment. Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• 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.
• 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.

In this role, you willberesponsible for conducting analytical testing with a focus on performance and functionality testing (force testing) and container closure integrity (CCI) assessments in compliance with Good Manufacturing Practice (GMP) regulations. This role involves method execution, documentation, and collaboration with cross-functional teams to ensure the quality and integrity of pharmaceutical packaging. The ideal candidate will have experience with physical and mechanical testing methodologies, strong analytical skills, and a thorough hands-on understanding of GMP requirements.

• Conduct performance and functionality testing using force-based technique (Instron machine).
• Conduct container closure integrity (CCI) testing using helium leak technique.
• Use instrumentation both qualitatively and quantitatively where appropriate. Independently troubleshoot instrumentation.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Collaborate with cross-functional teams.
• Willingness to learn and apply new analytical techniques.
• Perform lab investigations, OOS, and OOT as required and resolve problems in the lab.
• Apply required cGMP regulations and follow all policies and procedures.
• Apply internal QA procedures.
• Adhere to established laboratory safety procedures.
• Other duties as assigned.

• Bachelor’s degree or equivalent experience in chemistry, engineering or closely related fields.

• Minimum 3 years of professional experience in a GMP lab environment required
• Experience in pharmaceutical or packaging field and implementing laboratory training programs required

• Working knowledge and experience with at least one of the skills below
  • Physical / mechanical testing such as Instron or Zwick
  • Container closure integrity (CCI) via helium leak
• Experience in analytical testing in GMP environment.
• Ability to work independently, with minimal guidance and an attention to detail
• Able to comply with all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety policy at all times.
• Able to follow directions, prioritize tasks, and work independently.
• Must have excellent interpersonal, written and verbal communication skills.
• Must be proficient in Microsoft Office tools and capable to learn other software programs.
• Able to review regulatory code and learn safety standards.

• Physical:
  • Must be able to stand for long periods of time.
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures).
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents.

In this role, you will be responsible for planning, organizing, and leading projects to support the development of new packaging systems and or components that enhance and preserve West’s high value products. The ideal candidate will drive technical projects, work with cross-functional development teams, and work with strategic suppliers to develop new packaging systems for West’s HVP offerings. You will act as a subject matter expert for system and component packaging and drive technical decisions which support West’s business objectives. Key responsibilities include project management, testing coordination and execution, specification / drawing development, Design History File (DHF) documentation creation and cross functional collaboration while engaging with various project teams and functional groups. As a Senior Engineer, you will be responsible for mentoring more junior engineers within the group and identifying innovative solutions to broaden West’s portfolio. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals
2. Work independently only with strategic guidance in the most complex situations
3. Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

• Technical packaging lead for Integrated Systems R&D efforts related to product design and development processes from conceptualization to commercialization.
• Engage with cross-functional teams that include R&D, Pharma Processing, Marketing, Regulatory, Quality and Supply Chain to develop new packaging solutions.
• Develop innovative packaging solutions to support business growth and to enhance West’s position as an industry leader in drug delivery.
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for development of new packaging solutions. Maintain effective communications and working relations with all external parties.
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories.
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Other duties as assigned.
• Maintain effective communications and working relations with all external parties.

• Education or Equivalent Experience: Bachelor's in Packaging, Mechanical, Materials, or Chemical Engineering, or related engineering discipline
• Master's degree preferred

• Experience: 5-8 years of experience in development of packaging, medical devices, or combination products
• Previous experience in packaging development of sterile barrier systems
• Experience leading technical projects from concept through commercialization
• Experience in working under requirements of Quality Management System in a regulated environment
• Experience in communicating complex technical concepts to customers and internal stakeholders

• Thorough understanding of global testing standards and regulatory requirements related to sterile barrier packaging
• Excellent interpersonal and written/verbal communication skills
• Working understanding and application of fundamental engineering principals.
• Strong technical writing abilities.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy and quality at all times.