MS&T Senior Engineer

Overview: The MS&T Senior Engineer is accountable for the new introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. The Senior Engineer, MS&T authors, leads, and updates the Technical Transfer Plan and Gap analysis. He/she trains the operational teams on the protocol/master batch record for the new product. He/She acts as a role model and mentor for less experienced colleagues. Responsibilities: Functions: Lead risk assessments and risk management cross-functional teams (from draft to approval). Lead projects and initiatives as directed by the client, to be completed autonomously using the project management tools and approach. Accountable and responsible for Tech Transfer and Gap Analysis and follow up approval flow within the electronic documentation system and facilitate all stakeholders‘ input to ensure documents are updated and approved in a timely manner internally and with the client. Accountable for developing the technical transfer plan and gap analysis of new products in collaboration with bulk, packaging, NPI QC, and quality departments. Responsible as a Subject Matter Expert (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 the operational team, provide feedback/input to the NPI management). Support: Support in alignment with QA for the Critical Quality Attributes and Critical Process Parameters definition and implementation. Act as quality system and GMP Documentation support for the manufacturing Ops team. 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. Contribute actively to continuous improvement initiatives, including proactively identifying problems, gathering input from the operational team, and proposing solutions. Establish clear improvement plans. Follow-up: Follow up and implement assigned CAPAs. Follow up approval flow within the electronic documentation system and facilitate all stakeholders‘ input to ensure documents are updated and approved in a timely manner. Qualifications: Experience / Education: BS/MS in Engineering/Technical discipline or equivalent experience. 10 – 15 years‘ experience in the pharmaceutical industry with a proven track record on New Product Introduction, solid dosage forms, and validation. 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. Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes. Well-developed ability to constructively work across functional teams to achieve results. Strong verbal and written communication skills. Strong analytical, problem-solving skills. Communicate positively and in a winning and persuasive manner. 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. #J-18808-Ljbffr