Manufacturing Engineer

BIOVECTRA, now a part of Agilent, is recognized as a leader in the contract development and manufacturing space of active pharmaceutical ingredients specializing in clinical-to-commercial scale production for microbial fermentation, synthetic small molecules production, including ADC, HPAPI, plasmid DNA, mRNA, LNP and sterile filling capabilities. With over 650 employees at both the Windsor, NS and Charlottetown, PEI sites, BIOVECTRA supports over 100 clients, including over 20 top pharmaceutical and biotechnology manufacturing companies. 

BIOVECTRA joined Agilent in 2024 and is part of Agilent’s Advanced Manufacturing Partnerships Division (AMPD), which also contains Agilent’s Nucleic Acid Solutions Division. With BIOVECTRA, Agilent aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence. Within AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advanced manufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics. 

The Manufacturing Engineer will be responsible for assigned duties related to the design, procurement, installation, commissioning and qualification of new pharmaceutical processes and equipment. The Manufacturing Engineer is responsible for commissioning manufacturing systems and inspecting the construction and operation of the equipment. Working closely with maintenance, the engineer will provide sound advice as a subject matter expert. This position will ensure all projects are delivered to meet the project timelines, budgets and applicable quality standards (GXP, ISO, ICH) as well as the applicable regulatory legislation (OHS, CSA, NFPA, CEPA, etc).

• Prioritizing and executing assigned project deliverables, including adherence to budgets and schedules, coordinating project startup, commissioning and qualification activities with internal and external groups.

• Startup of new process equipment and instrumentation, troubleshooting equipment and instrumentation during commissioning activities.

• Assembling and reviewing Turn Over Packages (TOP) for systems and equipment. Developing Equipment Qualification protocols and execution of these protocols. Data collection and statistical analysis.

• Developing and updating ACAD drawings. Reviewing and updating "As Built" drawings in coordination with outside contractors.

• Coordinating project startup, commissioning and validation activities with internal and external groups.

• Supporting trades people (electrical, mechanical, and structural) by providing advice or guidance.

• Conferring with vendors to determine product specifications, purchase equipment, materials or parts, materials of construction (“MOC”) and evaluate products according to quality standards.

• ·Processing, equipment and engineering improvements/modifications to existing manufacturing equipment. This includes mechanical, electrical and instrumentation installation and improvements.

• ·Researching technical information for the installation, installation, maintenance, and operation of instruments and equipment. Determining the critical testing requirements for instrumentation and equipment prior to qualification.

• ·Assisting maintenance department with repair, calibration, and sourcing replacement parts, as required.

• ·Participating in project meetings between engineering, manufacturing and client.

• Participate in P&D, HAZOP, PHA and other design reviews

• Organizing project paperwork, drawings and files

• ·Additional duties assigned, based on business needs and the department supervisor’s request.

• Ability to anticipate issues and trends which could impact clients and projects.

• Energetic team player but able to work effectively independently.

• Ability to function effectively under ongoing pressure and flexibility to change.

• Enthusiastic and willing to expand on responsibilities and professional abilities.

• Project management experience would be an asset.

Education:

• Bachelor of Science in Engineering (Mechanical/Chemical preferred)

• Six Sigma or Lean Certification would be an asset

• PMP is considered an asset

• Red Seal trade or CET designation considered an asset

Experience:

• 5+ experience in a pharmaceutical manufacturing or similar regulated environment.

• Hands on experience with the starting up and commissioning instruments and process equipment.

• Possesses financial acumen, understands business metrics, and how to impact results. Ability to communicate effectively, both written and orally.

• Basic understanding of fire and building codes and applicable quality and regulatory standards.