Production Supervisor - Assembly Nights jobs at West Pharma

• Overall ownership and accountability for developing, leading and driving new business development for DDD OU product platforms for identified strategic accounts to achieve revenue growth targets for commercial and product development sales.
• Advance the vision for strategic partnerships and customer opportunities as the SME for device services offerings, for all direct assigned accounts and regions. Establish business development programs including early adopter customers, target service levels, and CDAs (Customer Development Agreements).
• Responsible for driving the prospecting and lead development, monitoring sales and funnel performance. Lead and support customer facing teams in key customer interactions/strategic partnerships throughout the selling journey including critical customer/strategic collaboration, presentations, post-sales leadership and problem solving to deliver on revenue and growth targets.

• Bachelor's in Engineering, Science or Business-related discipline

• Minimum 15 years of experience in B2B, Combination Products, Business Development, Product/Program Management.
• Indepth knowledge and experience in pharmaceutical/medical device technical development, sales, marketing or related business.
• Experience in successfully leading global multi-functional or cross-functional teams, in developing cohesive relationships and producing strong business results.
• Excellent communication/negotiation/influencing skills and strong customer focus.
• Excellent commercial and financial acumen.
• Self-starter, highly motivated and ability to work independently with little or no daily supervision.

• MBA or master’s degree preferred
• Background with a good technical understanding and knowledge of Combination products, medical device qualification, primary packaging, Regulatory requirements and Program Management.
• Significant leadership team experience and executive leadership exposure.

• • Supervise shift personnel in the manufacture of customer products consistent with high safety and quality standards.
  • Troubleshoot problems arising on the shop floor as it relates to Advanced Manufacturing operations / products, in conjunction with quality standards for throughput and yields with the appropriate engineering support from Engineering functions within the value stream.
  • Maintain close observation of orders to keep informed of manufacturing status and, when needed, initiate the necessary steps to conform to schedule / staffing requirements.
  • Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among plant team members.
  • Recommend and implement measures to motivate team members and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
  • Routinely evaluate team member performance and identify training needs. Coach and counsel team members for performance, attendance and behavior. Participate in the resolution of team members relations issues.
  • Review and approve work time in the appropriate timekeeping system. Maintain and verify accuracy of the hours each team member has worked.
  • Adjust direct labor to support demand and manage available resources to ensure on time production and delivery of customer orders with consistent focus on labor absorption.
  • Ensure Safety regulations, OSHA, SOPs, and cGMP are followed.
  • Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and generate work orders where appropriate.
  • Network with internal and external customers and other departments as appropriate.
  • Actively participate in site wide Safety Committee Team / projects.
  • Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
  • Participate in special project teams as assigned.

• Education: Bachelor's in a technical discipline to include Business, Operations or Engineering preferred

• 5-8 years of experience in a manufacturing environment, including supervisory experience

• Working knowledge of repetitive process, high tech, manufacturing – mechanical automated systems.
• Must possess strong leadership and managerial skills
• General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation
• Working knowledge of business and shop floor systems to effectively manage operations; prefer SPA and MS Office applications.
• Experience working with ISO9000, FDA and cGMP required.
• Ability to speak effectively before groups and employees in the organization.
• Understanding and experience in use of Lean manufacturing principles to be able to 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.

• Health Services\First Aid Certification Upon Hire preferred or
• Health Services\CPR - Cardiac Pulmonary Resuscitation Upon Hire preferred

• Self-motivated and solution-oriented personality.
• Excellent written and verbal skills.
• Good communication, project management, and interpersonal skills.
• Good organizational skills.
• Effective problem-solving skills.
• Must wear safety toe shoes, safety goggles, and hearing protection, as required, in production areas.
• Must follow and comply with Plant’s Dress and Hygiene Code (SOI).
• Must follow and comply with all Company and Plant policies, procedure (SOIs), rules and State and Federal laws

• Under the supervision of a trainer or supervisor perform the following duties...
• process trimmed product through washing and drying process per site SOI’s and work instructions.
• Ensure that the equipment is set up accurately.
• Ensure continual flow of product through the module from the mold press thru the trim press.
• Operate a mold press to produce molded panels of product following site SOI’s and work instructions.
• Operate a manual / automatic trim press as needed following site SOI’s and work instructions.
• Process product through any required special treatments such as sort, silicone, chlorination, etc.
• As needed, set up pack scales for weighing and packing of finished product and prepare carton labels for boxing and shipping.
• Alert the Area Supervisor to conditions that may prevent meeting production and quality expectations.
• Accurately maintain all required documentation and paperwork to ensure product traceability.
• Inspect molded/trimmed work to ensure quality product is being produced.
• Move materials into and out of the area as required.
• Properly clean and prep assigned workstations/equipment during and prior to the next available shift.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

• High School Diploma or GED required

• 1-3 years manufacturing experience preferred

• Must possess an acute attention to detail
• Basic computer skills, i.e. use a mouse/keyboard.
• Ability to apply Good Manufacturing Practices (GMP)
• General use of computer work station and ability to use SAP commands is preferred
• Must be willing and able to work as a team member and make general decisions within authorized job responsibilities
• Must be able to train and guide others as required.
• Must be able to read and write in English

Management and implementation of facility projects and support in holistic building management. Perform a wide variety of mechanical, as well as pneumatic maintenance activities and some basic electrical activities on various pieces of equipment to maintain safe operations of equipment while maintaining production goals and quality standards. Other responsibilities include sourcing parts for obsolete parts and ordering them, documenting all the maintenance activities performed, PM's, installation, and validations of equipment. Will support and help other groups like Process Engineering, QA, and Facilities in resolving problems, improvements, investigations etc. In this role you will service/maintain several machines, while learning the others in the department. Work from prints, sketches, sample parts, verbal or written instructions. Interpret drawings, select material plan, and layout work in proper operational sequence. Maintain and setup vision systems during production.

• Identify problems by reading schematics/prints, where available, and make necessary repairs on the equipment or system to ensure safe operation of the machine or system.
• Respond to production maintenance request and any unscheduled down time.
• Troubleshoot and adjust or repair ancillary equipment like blow overs, bulb pullers, and heaters.
• Changeovers and setups on Vision Systems, make minor adjustments as required.
• Perform ink mixing as well as disposing of procedure as per set Safety/QS guidelines for printing machines.
• Perform necessary oil changes on machine gear boxes and dispose of used oil per established procedure.
• Rebuild/retrofit machine or machine components as per specifications.
• Perform installation, replacement or decommissioning of equipment.
• Perform validations as necessary for equipment.
• Work with training department to train new mechanics on machine repair, setup and related plant procedures.
• Complete PM's on or before the due date and communicate to proper authority of job completion.
• Source obsolete parts for equipment and make them stock item.
• Identify and locate parts in the stock room through MP2 or other such system.
• Participate in various company run programs like Continuous Improvement, Safety initiatives, audits, investigations etc.
• Support projects and improvement initiatives from engineering, process, QA, Safety and Operations groups.
• Document performed tasks for the day into the maintenance log before the end of each shift.
• Safeguard all corporate or plant confidential information.
• Use good housekeeping practices to maintain safe, (safe is always first) clean, orderly work area.
• Upgrade technical skills by various educational workshops, on-site or off-site trainings supported by WEST.
• Follow engineering department guidelines and procedures.
• Conforms with and abides by all safety rules, regulations, policies, work procedures and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.
• Implementation and collaboration of facility projects

• High School Diploma Or GED required

• 3 years manufacturing maintenance experience

• Experience with plastic injection molding preferred.
• Experience with robots and pick in place robots.
• Experience with ISO 9000 standards and GMP’s.
• Excellent communication and interpersonal skills.
• Experience with SAP or similar software for maintenance tracking.
• Agile working style.
• Ability to work weekends and overtime as required

This Full-time onsite role will be supervising, coordinating and administering the site Quality Control systems compliance: Document Control, Nonconformance/ Deviation Reports, OOS Process, Measurement Systems, Change Control, Calibration and CAPA’s. Supervise and support internal projects and ensure cGMP compliance, applicable ISO requirements, company policies and procedures.

• Qualify inspectors to independently perform responsibilities for competency/ proficiency capabilities in inspections, measurements, sampling, Quality audits and defect recognition.
• Qualify and/or support qualification of team members for competency/proficiency in defect and quality incident recognition/escalation.
• Train inspectors in deviation/non-conformance/OOS record initiations, escalations, how to perform containment/bracketing, and initial event triage activities.
• Ensure deviation/ nonconformance reports and OOS’s are completed properly, including root cause investigation (if required), effective corrections and actions closed within an established goal.
• Monitor and enforce compliance to a high level of work standards across the QC functions. Ensure that jobs are carried out efficiently. Paperwork is maintained accurately in accordance with Company policies, Regulatory standards and Training.
• Perform various SAP transactions for maintaining proper product disposition for release criteria and inventory control.
• Analyze data and provide reports/ recommendations to Management for continuous improvement.
• Submit periodic reports on the status of compliance to Quality System requirements.
• Review Customer specifications and ensure requirements are translated into site procedures and documentation as needed.
• Provide for Quality planning by preparing inspection plans and documentation controls.
• Support facilities, equipment and process validations. Approve engineering studies and other protocols as required.
• Ensure proper completion of Change Controls and monitor timely completion when required.
• Monitor completion of MSA’s for critical measurement systems and provide recommendations for gauging improvements.
• Provide expertise and guidance for statistical methods in Production.
• Conforms with and abides by all regulations, policies, work procedures, instructions and all safety rules.
• Performs other duties as assigned based on business needs.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

• Highschool Diploma required.
• Bachelor's degree in Quality, Engineering, Science or equivalent experience preferred.

• Minimum of 3 years of related experience analyzing information, documentation skills, promoting process improvement and safety management.
• Minimum 1 year of leadership experience or demonstration of leadership skills routinely as part of previous/current role(s)

• Demonstrate a high degree of proficiency in Excel, Word and other Microsoft Office Programs required. Demonstrate oral and written communication skills.
• Familiarity with a variety of Quality concepts, practices, AQL sampling plans for attribute and dimensional inspection. Demonstrate ability to investigate problems and issues in order to determine root cause analysis.
• Familiarity with GMP/GDP Regulations
• 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 make independent quality decisions under pressure, if necessary
• 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 environment requires strict adherence to standards. Working environment is a manufacturing facility and must be able to tolerate fumes and particulate generated from the processes.
• Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.
• Must work constructively in an environment that may have competing resources, while maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other facilities when necessary.
• 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.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• 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
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual

1st Shift Position, with occasional adjustments to accomodate 2nd/3rd shift interactions

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

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

• Develops and implements policies and procedures for production operations
• Plans, examines, analyzes, and evaluates production operations
• Prepares production reports, reviews operating and financial data and makes recommendations for improvements
• Evaluates work performance and initiates personnel actions such as recruitment, selection, promotions, transfers, and disciplinary measures
• Resolves grievances, investigates customer complaints, and proactively participates in problem resolution
• Directs and coordinates work and production schedules and general department activities through subordinates
• Lead continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment
• All interactions, workflow, productivity levels, and quality standards are implemented with a “Customer Service” approach to both internal and external customers
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
• Exhibits regular, reliable, punctual and predictable attendance
• Other duties as assigned
• Commercial leadership and management of the customers allocated, including full PandL responsibility for all operational aspects
• Lead and drive the highest standards in operational performance in the development, tracking and reporting of business key performance indicators
• Build and maintain an excellent working relationship with the customer in the successful delivery of all client related projects (on time, within budget and in accordance with customer requirements/specifications).

• Bachelor's Degree in relevant engineering discipline required and
• Master's Degree in relevant engineering discipline preferred

• Minimum 8 years related experience required
• 5-10 years of experience working with injection molding processes 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.
• Strong analytical and problem solving skills
• Excellent commercial acumen and customer relationship building skills
• An ability to lead in matrix structure multiple projects on-time to budget