The MS&T Engineer is involved in the new 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 Product transfer. He/she authors the technical transfer plan and the Gap analysis He/she trains the operational teams to the protocol/master batch record for the new product.

Experience / Education

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

Knowledge / Skills / Abilities:

• Sound knowledge of current international GMP regulations
• Knowledge of pharmaceutical facilities, manufacturing,
• 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

• The MS&T Engineer main activities are completed autonomously using the project management tools and approach. Either as a team member of a project or responsible for the whole project.
• Accountable for Tech Transfer and Gap Analyse and follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner internally and with the client.
• Act as a SME for manufacturing topics with customers for the assigned project.
• Is the key contact for manufacturing topics related to new product introduction (collect the input from operational team, provide feedback/input to the NPI management).
• Accountable through developing the technical transfer plan and gap analysis of new products in collaboration with bulk, packaging, NPI QC and quality departments.
• Support the manufacturing and packaging activities related to the new product introduction on-the-floor with the production team if necessary.
• Support the Initiation of deviations by the production compliance officer and participate in the floor investigations, if needed. Partner with QA and Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
• Support risk assessments within cross functional teams lead by QA (from draft to approval).
• Support Critical Quality Attributes and Critical Process Parameters definition and implementation.
• Contribute actively to continuous improvement initiatives, including proactively identifying problems, gathering input from the operational team and proposing solutions. Establish clear improvement plans.