Process Specialist II

OverviewNovocol 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, a global pharmaceutical and medical device company with a 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 three openings available for a Process Specialist II.Job SummaryThe 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.ResponsibilitiesManage 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 quality.Lead continuous improvement initiatives.Analyze and support validation for both qualification and requalification activities.Support relevant R&D projects, and new product launches.Audit and approve protocols, drafts and executed reports.Initiate independent studies analyses and interpret data, and make conclusions.Provide technical guidance to less experienced engineers and technicians working on common projects.Write commissioning and startup documentation.Design, reformats, and amend Standard Operating Procedures (SOPs) as required.Prepare, revise, and interpret conceptual layouts, as-built drawings and schematics for process and plant equipment.Maintain a high level of pharmaceutical compliance and regulatory safety in all aspects of work.Work harmoniously with all fellow employees.Perform other duties as required and support the validation department in validation projects.Follows GMP and regulatory requirements, and ensures quality standards are met.Observe and support all safety guidelines and regulations.Model the Company Mission, Vision and Values Statements, policies, and current standard business practices.QualificationsEducation: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 skills.Demonstrates 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 PLCs / 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%).What we offerExcellent compensation/benefits package.Bonus and reward programs.Discounted gym memberships.Programs supporting work life balance.Employee recognition program.Professional and personal development programs.Social events and spirit days.We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview. In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.Recruitment Fraud– please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.Contract typePermanent #J-18808-Ljbffr