דרושים מנהל הנדסה ב-West Pharma ב-United States, Walker

Effectively plan and guide Engineering department, ensuring quality product at a minimum cost.

• Leads the site engineering department for the execution of new projects, maintain current production lines in optimal performance, Expansion plans and facility modifications.
• Provide engineering assistance to assure plant, machinery and processes are at an optimum level.
• Provide assistance and make recommendations to Division Engineering on a timely basis.
• Administrate maintenance management software.
• Ensure plant is in compliance with OSHA and local, state and federal environmental regulations.
• Routinely evaluate and review employee performance.
• Write validation, user requirements, equipment specification and other documents as needed.
• Promote and support a Lean Manufacturing environment within the facility.
• Improve processes and procedures to manufacture a quality product at a minimum cost.
• Quotes new molds, engineering services, automation, etc. for new and existing customers. Develops suppliers and maintain audit. Develops design concepts for new molds.
• Provide leadership to engineers. Provide and schedule tools and supplies for departments. Assume responsibility for various engineering projects as assigned.
• Facilitate meetings with the customer both on and off site to determine the needs, requirements, and customer specifications. Establishes relationships with customer and tooling suppliers in pursuit of win‐win results and ongoing business.
• Provide and schedule training for the department. Purchases tooling related equipment in accordance with the company policy.
• Responsible for project cost accounting and delivering projects on schedule and at budget.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintain machine and plant equipment drawings.
• Manage and oversee the functioning of the site engineering and maintenance groups.
• Develop initial project scope, timeline, savings and cost estimations.
• Write Project and Capital Request and project justification documents.
• Develop equipment requirements.
• Research new technologies and methodologies to use in the plant.
• Present justification to management and/or customer to attain approvals.
• Lead project teams and team meetings as required.

• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance .

• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly and safe workstation and environment at all times.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
• Exhibits regular, reliable, punctual and predictable attendance. Performs other duties as assigned based on business needs.

• Education or Equivalent Experience:​Bachelor's in​Engineering or Science field is preferred.

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate odors, fumes, particulate and loud noises generated from plastics manufacturing and molding processes.
• Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• Must be able to work in a controlled clean room and/or white room environment requiring special gowning. Will be required to follow hygiene and gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• Ability to stand and sit for extended periods of time.
• Requires occasional bending at the waist, twisting (at the torso and neck), crouching, climbing, kneeling, balancing, reaching (including overhead), pushing, pulling, grasping, holding and manual dexterity.
• Must transport oneself to and from other areas of the facility when necessary.
• Ability to understand verbal or written directions, which may include reading English and understanding symbols and warnings.
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Must be able to lift a minimum of 25lbs.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for technicians.
• Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Education: Associate degreein Engineering or Science field

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.
• Some validation experience – computer systems, equipment and process required and

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• 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 and quality policy at all times.

• Manufacturing\Lean Six Sigma Certification-IASSC or Agile preferred
• Program and Project Management\Certified Project Management Professional (PMP)-PMI Knowledge of Agile and Waterfall methodologies preferred

In this role, you will supervise technicians in a manufacturing environment and be responsible for maintaining equipment of automated assembly lines. You will be the first point of contact during the escalation of any technical issues regarding automation during your teams’ shifts and will be responsible for teaching and encouraging growth in all night shift technicians.

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for night shift technicians under your supervision. Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Associates in Engineering or Science field is preferred.

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• 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 and quality policy at all times.

• Must be able to perform job duties as required with limited physical demands.

In this role, you will act as a trusted HR senior advisor and partner to the Grand Rapids Senior Leadership team. With a team of HRBP direct reports and functional support like talent acquisition and learning in a matrix organizational design, this will till support and drive all aspects of the Grand Rapids workforce management. As part of a $3B global enterprise, you will collaborate and partner with the appropriate HR leaders to provide support to managers and employees within the defined HR strategy and principles. You will have responsibility and accountability (liaising as need with teams such as Compensation, Payroll, Talent Acquisition, etc.) for onboarding and off boarding, legal/employee relations, training, culture, engagement, performance management, job description management, compensation, and benefits. A successful HR Leader will demonstrate effective and empathetic leadership and communication skills to drive organizational consensus, operational and business results and set workforce priorities. This role will continuously identify and implement strategic and efficient HR solutions. You will operate as a key liaison between employees and the company to provide a world class workplace.

• Provide HR Leadership and direction for the site/multiple sites within your scope of responsibility.
• Supervise and provide guidance to direct reports.
• Approve hiring, firing and investment requests; and manage overall HR financial budget.
• Develop organizational objectives and facilitate goals creation for broader functions.
• Work with senior management and other peers for strategy development and execution plan.
• Guide the talent identification and development processes.
• Oversee employee performance and communicate goals results.
• Use in-depth expertise and experience to provide HR manager business partner support for various HR initiatives: performance and talent management, change management, workforce planning, leadership and employee development, onboarding and offboarding, compensation planning and benefits administration.
• Act as a trusted senior advisor to provides advice, clarification and follow-up on policies, procedures, benefits and compensation related items for employees, managers and global HR partners. Interprets and administers HR policies, procedures, guidelines and programs, always ensuring alignment with global West in a consistent manner.
• Perform other duties as assigned based on business needs.

• Bachelor's Degree in Business, HR or related field. required
• Master's Degree in Business, HR or related field. preferred

• Minimum 10 years experience in Human Resources and role of HR Generalist and/or HR Manager. required and
• Deep experience and knowledge of multiple HR disciplines. preferred and
• Experience with HR business systems. preferred

• Leadership.
• Change Management.
• Wide knowledge of federal and state employment law.
• Strong consultative, interpersonal and client orientation skills.
• Ability to work both independently and in a team environment.
• Capacity to handle confidential and sensitive information and issues in a discrete manner.
• Ability to work in a fast-paced virtual environment in a global organization.
• Trustworthy, inclusive, communication and presentation to diverse and large audiences, decision making, planning and organizing, personal accountability and attention to detail.
• Ability to prioritize and respond timely to changing requirements and to coordinate multiple tasks simultaneously.
• Knowledge of MS Office applications.
• 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 and quality policies

• Human Resources\PHR or SHRM-CP Upon Hire preferred and
• DDI certifications. Upon Hire preferred

• 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.
• Position operates in a professional office environment. May stand or sit for extended periods of time.
• This role routinely uses 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.

• Directs and leads the Quality function for combination medicinal products, investigational medicinal products (IMP) and medical device products and components moulded, assembled, and packed by West, Grand Rapids to meet and exceed all regulatory requirements, customer requirements and key performance indicators.
• Serve as an internal subject matter expert in the development and execution of Quality Management System Compliance to Medical Device and Pharmaceutical regulations for Combination products and Drug Handling
• Deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
• In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
• Management representative responsible for the implementation and maintained integrity of the quality system
• Leads, develops, and executes on the local quality strategy for the Grand Rapids site, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing quality objectives.
• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations.
• QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
• Direct and oversee the Quality Assurance, Quality Engineering, Quality Systems and Quality Program teams.
• Lead the engagement and interaction with key internal customers specifically Program Management, Operations, Engineering and Continuous Improvement teams and will be first point of contact for key strategic external customers.
• Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines
• Manage the customer satisfaction processes and lead improvements of overall customer satisfaction if discrepancies are identified.
• Directs Grand Rapids in line with Sister Site agreement requirements for products manufactured at other West sites.
• Leads regulatory agency interaction related to compliance to local and regional guidelines/ regulations and develops strong internal and external relationships with regulatory bodies and authorities
• Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
• Responsible and accountable for quality departmental budget
• Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and combination products.
• Direct and leads the facility readiness for all third part audits including notified bodies.
• Leads alignment and standardization of best practices and enterprise excellence across all West sites producing Customer or West owned platform devices.
• Play a role as a key contributor to Global Enterprise Quality documentation updating, including where appropriate, leading any updates
• Leads by example and sets the highest standards in employee engagement and communication to inspire innovation and quality excellence
• Other duties as assigned based on business needs

• Bachelor's Degree required, preferably mechanical engineering, chemical engineering, manufacturing engineering, or industrial engineering

• Minimum 10+ years in medical device/pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
• Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements.
• Proven track record of implementing process improvements and ensuring compliance with regulatory standards.

• In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements such as 21CFR Part 820 for Medical Devices and 21CFR Part 210, 211 & Part 4 as applied to combination products.
• Strong knowledge and understanding of ISO13485, ISO9001, and other international regulations.
• Experience in Quality Leadership in a Manufacturing environment for Drug Packaging of Combination Products
• Familiarity with document management databases, particularly MasterControl and SAP.
• Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
• Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).
• Excellent organizational skills with an ability to think proactively and prioritize work.
• Working knowledge of statistical data analysis
• Thorough understanding of validation activities and risk management principles and techniques
• Strong problem-solving and critical thinking skills
• Medical industry or highly regulated industry

• Work in a manufacturing environment, subject to heat and cold as well as loud noise.
• Work in an office environment. At times must sit for extended periods of time.
• Ability to effectively communicate and comprehend complex ideas and concepts.
• Use written and oral communication skills.
• 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.