Process Specialist II

Apresentação da empresaNovocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.Our employees are our number one asset We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.We have an opportunity for a Process Specialist II.Descrição da vagaThe Process Specialist (II) is accountable to the Technical Services Manager for all activities related to project work and supporting process systems at Septodont – Novocol Pharmaceutical Division. This includes supporting the ongoing business, capital and regulatory items in any process related area of the company.Upon receipt of the Professional Engineer Designation (P. Eng.), incumbent may use the title Process Engineer.Informações adicionaisManage and lead varied engineering assignments and projects from specification to turnover which may involve the interaction with multiple departments.Provide ongoing technical support in any process area as required.Liaises regularly with internal customers to understand their technical service needs.Identify opportunities for continuous improvement of equipment and process in order to minimize downtime, turnaround time and waste reduction while maintaining the highest standard of qualityLeads continuous improvement initiatives.Analyzes and supports validation for both a qualification and requalification activities.Support relevant R&D projects, and new product launches.Audits and approves protocols, drafts and executed reports.Initiates independent studies analyses and interprets data, and makes conclusions.Provides technical guidance to less experienced engineers, and technicians working on common projects.Writes commissioning and startup documentation.Designs, reformats, and amends any Standard Operating Procedures (SOP’s) as required.Prepares, revises, and interprets conceptual layouts, as-built drawings and schematics for process and plant equipment.Maintains a high level of pharmaceutical compliance and regulatory safety in all aspects of work.Works harmoniously with all fellow employees.Performs other duties as required.Supports the validation department in validation projects.Follows GMP and regulatory requirements, and ensures quality standards are met.Observes and supports all safety guidelines and regulations.Models the Company Mission, Vision and Values Statements, policies, and current standard business practices.Performs other related duties as requiredPerfilEducation:Bachelor of Engineering / Engineering Science degree is a requirement (Chemical or Mechanical preferred).Experience:Minimum of 5 years’ experience in manufacturing environment, preferably in pharmaceutical, food / beverage or consumer packaging.Able to read and interpret architectural, mechanical, electrical, and P&ID drawings / schematics.Excellent communication, interpersonal and organizational skillsDemonstrates initiative, problem solver, team player and self-motivated.Has the ability to lead and take ownership on systems and projects.Experience in the use of PLC’s / control systems on process equipment.Experience in AutoCAD, MS Project, Word, Excel, PowerPoint.Experience in a Lean Manufacturing environment is an asset.Professional Engineer designation preferred.Able to travel internationally in support of projects (up to 20%) #J-18808-Ljbffr