Project Engineering Manager Jobs

Company Details

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridge 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 Project Engineering Manager.

Job Summary

The Project Engineering Manager is accountable to the Director of Engineering for providing leadership for project engineering and technical transfer activities at Septodont’s Cambridge facility, Novocol Pharmaceutical. The Project and Technical Transfer Manger oversees and directs the Project Engineering team to achieve goals and objectives related production equipment capital projects, process, and technology transfer for CDMO pharma projects and new dental products.

Responsibilities

• Ensures all project work is done in conjunction with the Validation team, to assure robust requirements planning and seamless transfer of knowledge and information from project planning and commissioning phases to qualification and validation phase.
• Tracks and manages local capital and operating budgets and reconciles discrepancies
• Performs other related duties as required.
• Collaborates with PD in DOE studies and technology sourcing for product and process requirements.
• Acts as an ambassador in modeling and promoting a safe work environment. Is accountable for the enforcement and monitoring of the Safety Program and holds managers accountable for enforcing safety rules / regulations.
• Leads engineering accountabilities for Novocol Pharma CDMO projects and new dental products
• Forecasts operating cost of the department and directs preparation of budget requests.
• Provides team support for commissioning and qualification planning and execution when needed.
• Leads FMEA and risk analysis for new manufacturing processes
• Oversees the management of designated local capital projects.
• Partnering with CDMO clients and internal Product Development or R&D, for technology transfer and determining manufacturing processes such as scale-up and line transfers.
• Leads, directs, evaluates, and develops a team in accordance with the companies Mission, Vision and Values Statements, policies, and current standard business practices.
• Maintains process related documentation and ensures departmental records, specifications, SOPs, Master Equipment Files, and all as-built and master set drawings are kept in compliance with Company, regulatory and legal requirements.
• Ensures compliance with GMP guidelines and ensures that all GMPs and SOPs are followed.
• Leads cross functional teams in equipment procurement, start-up, commissioning, and qualification. Owns the equipment handover process to production, maintenance, and the manufacturing engineering teams.
• Manages the performance and development of all direct reports. In conjunction with the Human Resources
• Provide subject matter expert support.
• Accountable for department operating budgets and reconciles discrepancies.
• Supervises the work of outside contractors or trades personnel when required.
• Identifies, justifies, and implements projects involving production equipment or process changes based on new product requirements, optimization, productivity, safety, or compliance drivers.
• Consults with, and operates in cooperation with Corporate Engineering team, and in compliance with Corporate Engineering policies and procedures and standards.

Qualifications

Education

• Professional Engineer (P. Eng.)
• Bachelor of Engineering Science degree

Experience

• Proven analytical and problem-solving skills with the ability to make sound business decisions.
• 7 to 10 years of related experience in a pharmaceutical manufacturing environment
• Demonstrated experience guiding conflict resolution and facilitating employee relations activities.
• Experience in tech transfer of formulation and fill-finish processes
• Proficiency in Microsoft Office applications, including MS Project.
• Experience in planning and execution of significant projects utilizing formal project management and operations methodology.
• Direct management experience would be an asset
• Proven knowledge of Health and Safety legislation and other Employment-related legislation such as the Employment Standards Act.
• Strong leadership skills with the ability to coach and develop staff, as well as work with cross functional teams.
• Sterile experience would be considered an asset.
• Experience in liasing with external clients in project teams
• Effective communication skills, both written and oral.

What we offer

• Discounted gym memberships
• Excellent compensation/benefits package.
• Bonus and reward programs
• Professional and personal development programs
• Social events and spirit days
• Programs supporting work life balance
• Employee recognition program

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.

Internal Job Posting Grade 12. The due date for internal applicants to apply for this role is July 10, 2023.

Contract type

Permanent