Manufacturing Engineer

Job Summary:

The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she trains the operational teams to the protocol/master batch record for the new product.

Essential Job Functions:

The Manufacturing Engineer’s main activities are completed autonomously for the following tasks and responsibilities:

• Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, transfer protocol, master batch record, Forms and logbooks. Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
• Is the key contact for manufacturing topics related to new product introduction (collect the input from operational team, provide feedback/input to the NPI manager).
• Act as a SME for manufacturing topics with customer for the assigned project.
• Develop the technical transfer plan and issue the documentation related to the manufacture/packaging of new products in collaboration with bulk, packaging, NPI and quality departments.
• Follow the manufacturing and packaging activities related to new product introduction on-the-floor with the production team.
• Train the operational team (operator, technician) to the protocol/master batch record as required.
• Initiate deviations and participate to or lead on the floor investigations. Partner with QA and Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
• Lead risk assessments within cross functional teams (from draft to approval).
• Support Critical Quality Attributes and Critical Process Parameters definition and implementation.
• Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.

Job Requirements:

Experience / Education

• BS/MS in Engineering/Technical discipline or equivalent experience
• 3 years’ experience in pharmaceutical validation, packaging or related field

Knowledge / Skills / Abilities:

• Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.)
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes
• Well-developed ability to constructively work across functional areas and levels to achieve results
• Strong verbal and written communication skills
• Strong analytical, problem solving, influential and deductive skills
• Capability to work with short deadlines and simultaneous activities
• Excellent organizational and project management skills
• Fluent in English and in French is mandatory