Assoc Process Eng Sterilization jobs at West Pharma

• Initiate, lead and coordinate improvements of existing processes globally on quality, service, HSE and cost within the standard known/approved process frame and using best practice knowledge
• Strongly support the implementation / roll-out of automation and new innovative processes and technologies in joint cooperation with the automation, engineering- and quality assurance teams and the plants.
• Manage the development of robust process for final industrial production in targeted plants.
• Assess current process status in all relevant West locations globally, define best practices, perform a gap analysis and manage the harmonization of this best practice to all sites involved.
• Engage in solutioning product or process related issues as needed.
• Support the introduction, start-up and validation of new equipment in the local sites.
• Support process or technology or product transfer projects between plants from a process stand-point.
• Evaluate and approve all change requests globally.
• Utilize six sigma tools in minimizing process variation and improving the quality of product produced.

• Bachelor's or Master's Degree in Engineering or another scientific area or equivalent experience required

• Minimum 3 years experience in a similar position within the manufacturing industry required
• Experience in Project Management preferred

• Good knowledge of LEAN and Six Sigma manufacturing principles (Green Belt certification)
• Knowledge of MS Office, statistical tools and Minitab
• cGMP knowledge
• Fluent English and German skills
• Self motivated, result- and solution-oriented personality
• Excellent communication skills
• Ability to successfully collaborate with teams across different countries and organizational levels

• Interacts with all departments pertaining to implementation of statistically established studies either for process improvements or establishment thereof.
• Ensure quality of all materials used in the process by developing and implementing effective reliable testing techniques.
• Ensure continued reliability of testing techniques by maintaining current knowledge of all technical and analytical information.
• Write technical reports as required to defend or support decisions concerning material acceptability.
• Establish and implement reliable procedures to ensure compliance with good manufacturing practices.
• Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget.
• Support the efforts of production in materials related areas as a technical advisor.
• Reviews data using InTouch and eDart software, for investigation of problems.
• Take appropriate action to ensure compliance with all safety, health and hazardous communication standards.
• Ensures that established policies, rules and regulations, and procedures are followed.
• Actively participate and comply with all West HSE programs and regulations.
• Maintain a neat and orderly work environment in accordance with West 6S program.
• Other duties as assigned.

• Associate or Bachelor’s Degree or equivalent on the job experience in a technical discipline to include manufacturing, industrial, materials or plastics.

• Experience: 3-5 years of job-related experience
• Knowledge of the basic principles of injection molding, systematic molding, mold design, mold assembly, and machine operations.

• Must have excellent interpersonal & problem-solving skills & be able to interface with employees at all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills.
• Must be familiar with computers and various software programs.
• Familiarity with SAP, Master Control or similar systems and databases, a plus.
• Knowledge of statistical tools and Minitab.

• 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.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Manufacturing\Six Sigma Green Belt Certification preferred

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.

In this role, you will organize, coordinate, or perform modifications, validations, and enhancements of processes, equipment, and tooling to new and existing products to ensure safety, maximum yields, quality, cost effectiveness and throughput of our processes.

• Support the plant’s continuous improvement efforts with the development and improvement of products and processes assuring the plant’s competitive position.
• Ensure compliance with cGMPs
• Guide, coordinate, or perform modifications, improvements or validations of existing or new products, processes, tooling, equipment, and related research and development activity.
• Provide training and guidance to production engineering personnel.
• Plan, schedule, or perform projects within the approved time schedules and budgets
• Keep Engineering Manager advised of any unusual situation which may impair or affect production or assigned projects
• Keep BOM and routes current
• Review procedures to ensure they reflect the most effective means and contain the most current and correct information
• Maintain engineering records and documents as required
• Lead the way in supporting the plant’s efforts in meeting the corporate and plant goals
• Review processes continually to ensure their quality
• Safeguard confidential information and maintain effective team member relations
• Performs other duties as assigned based on business needs as directed by Area Manager(s), Production Manager and/or Director, Ops.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance

• Bachelor's Degree in Engineering or another scientific area or equivalent experience required

• 5-8 Years of experience
• Lean/Six Sigma Training/Certification Preferred

• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in 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.

• Manufacturing\Six Sigma Green Belt Certification within 1 Year required

• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, solve problems, and prioritize
• Must be able to maintain confidentiality and resolve conflicts
• Ability to make independent and sound judgments
• Read and interpret data, information, and documents
• Analyze and solve problems
• Observe and interpret situations
• Work under deadlines with shifting priorities

• Initiate, lead and coordinate improvements of existing processes globally on quality, service, HSE and cost within the standard known/approved process frame and using best practice knowledge.
• Strongly support the implementation / roll-out of automation and new innovative processes and technologies in cooperation with the automation, engineering- and quality assurance teams and the plants.
• Manage the development of robust process for final industrial production in targeted plants.
• Assess current process status in all relevant West locations globally, define best practices, perform a gap analysis and manage the harmonization of this best practice to all sites involved.
• Engage in solutioning product or process related issues as needed.
• Support the introduction, start-up and validation of new equipment in the local sites.
• Support process or technology or product transfer projects between plants from a process standpoint.
• Evaluate and approve all change requests globally.
• Utilize six sigma tools in minimizing process variation and improving the quality of product produced.

• Bachelor's or Master's Degree in Engineering or another scientific area or equivalent experience required

• Minimum 3 years’ experience in a similar position within the manufacturing industry required
• Experience in Project Management preferred

• Good knowledge of LEAN and Six Sigma manufacturing principles (Green Belt certification)
• Knowledge of MS Office, statistical tools and Minitab
• cGMP knowledge
• Fluent English and German skills
• Self-motivated, result- and solution-oriented personality
• Excellent communication skills
• Ability to successfully collaborate with teams across different countries and organizational levels

• Responsible for the development and execution of sterilization strategies to ensure medical devices meet functionality and design standards.
• Perform risk assessments and validation studies to ensure the effectiveness and safety of sterilization methods and protocols.
• Develop, maintain, and update sterilization processes in compliance with industry standards and regulatory requirements.
• Work with R&D, Quality Engineering, and other departments to ensure product integrity during product introductions, sustaining changes, and transfers.
• Offer technical support and insight regarding sterilization processes and regulations to internal and external stakeholders.
• Analyze and monitor data to identify trends, driving improvements in sterilization processes.
• Identify, investigate, and resolve issues related to sterilization equipment and processes efficiently.
• Participate in audits to ensure compliance with regulatory standards, providing recommendations for continuous improvement.
• Train and mentor R&D teams on sterilization processes, procedures, and regulatory requirements.
• Oversee the commissioning, maintenance, and validation of sterilization equipment to meet operational and energy efficiency standards.
• Identify and drive process improvements initiatives and cost-saving opportunities related to sterilization systems.
• Manage regulatory filings and respond to inquiries from regulatory bodies concerning sterilization processes.
• Deliver progress reports and presentations to communicate activities and timelines to management and core team members.
• Adhere to West compliance and safety policies and procedures at all times.
  

• Bachelor's in Microbiology, Biomedical Engineering, or Chemical Engineering or related engineering disciplines required
• Masters Degree in related field preferred

• 5+ years of experience in development of sterilization, medical devices, or pharmaceuticals.
• Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) required.
• Experience leading sterilization development workstreams from concept through commercialization.
• Experience in working under requirements of Quality Management System in a regulated environment.
• Must have effective problem-solving abilities.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Able to comply with the company’s safety policy at all times.

In this on-site role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques. You may be assisting in developing procedures for instrumentation, test instructions, and test reports. You may coordinate the day-to-day receipt and shipment of samples in the laboratory and support the Laboratory team in administration and quality systems.

• Perform analysis using various established or experimental techniques, instrumentation, and/or test methods while following standard operating proceedures (SOPs).
• Uses critical thinking skills to analyze field failures to identify the root cause and documents findings per procedures. Is familiar with and utilizes a variety of root cause analysis methodologies to assess technical problems.
• Uses software tools (Salesforce, MasterControl, Microsoft Office Suite) to document and manage investigations.
• With guidance, assist in completing projects from protocol to final report.
• Uses strong technical writing skills to communicate findings in a technical, concise, and effective manner.
• Train new analysts as appropriate.
• Exercises creativity in developing new test / debugging methods.
• Keep current with new analytical techniques and technology.
• Assist in preparation of technical reports, work instructions, SOPs, qualification documentation, lab study design and preparation in study plans and protocols.
• Apply internal QA procedures and perform lab investigations, OOS, and OOT as required.
• Actively participate in and complete all appropriate training tasks in a timely manner and meet individual and departmental goals as required.
• Work independently and collaboratively with other technical experts, and laboratory management, making rational and sound decisions with self-motivation, adaptability, and a positive attitude.
• Support laboratory management in data quality-documentation, and archiving.
• Maintain compliance to cGMP and ISO requirements and established safety procedures.
• May utilize various inputs to schedule work, use Sharepoint, SAP, Excel files, and Word documents. Proficiently use MS Office products for data gathering, reporting, and data entry.
• May handle Test Requests – write, review, and approve, and maintain traceability of samples.

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field preferred
• High School Diploma required

• No min required 0 - 3 years of experience required and
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory administrative/Coordinator/Analyst role preferred

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Knowledge of one of these skills: Container Closure Integrity, Physical / Mechanical testing such as Instron / Zwick, Particle Testing (HIAC, particle isolation, filtration and microscopy), Dimensional analysis (Smartscope or optical comparators)
• Method development and validation
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• 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
• Able to comply with the company’s safety and quality policies at all times

• 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
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• 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 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 follow directions, 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

The Process Technician is responsible for safely implementing, optimizing, and sustaining injection molding processes, molds, and equipment to consistently produce high-quality products for our customers. The role requires strict adherence to all safety, and processing protocols. The Process Technician must maintain a clean and safe work environment per the West 6S program, perform regular preventative maintenance, and assume material handling duties as needed. Additional responsibilities may be assigned to support operational objectives.

• Maintain the injection molding process definition for all jobs.
• Utilize statistical analysis of process data, along with troubleshooting techniques, to redefine and improve processes that fail to meet established product criteria.
• Properly document corrective actions using Good Documentation Practice standards (GDP).
• Ensures that established policies, rules, regulations, and procedures are followed.
• Effectively communicates between all departments.
• Safely and properly installs tooling and applicable auxiliary equipment.
• Completes all prerequisite tasks and documentation for starting a production tool.
• Effectively perform scheduled preventative maintenance of tools and equipment.
• Actively participate and comply with all West Health Safety Environment (HSE) programs and regulations.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Compliance with the company’s quality policy at all times.
• Additional duties as assigned.

• High School Diploma or GED required

• Minimum 3 years experience in a mechanical related field.
• Preferred: Minimum 3 years of injection molding – machine start up and shut down – mold pull / set activities – Setup and operation of 3 axis robots.

• Ability to analyze details and strong problem-solving abilities.
• Strong communication and teamwork skills.
• Ability to interpret and apply work instructions.
• Ability to obtain a Powered Industrial Truck (PIT) license.
• Ability to read mechanical diagrams and schematics.
• Ability to read and interpret technical drawings, blueprints, and process control documentation.
• Possess a fundamental mechanical aptitude of mechanical principles and concepts.
• Proficient with Microsoft Office.
• Demonstrated ability to perform root cause analysis to identify and address underlying issues in production processes, improving efficiency and product quality.