MS&T Senior Engineer

OverviewThe MS&T Senior Engineer is accountable for the new introduction of oral solid dosage forms (capsules and tablets) at our Couvet, Switzerland site. The MS&T Senior Engineer 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 and acts as a role model and mentor for less experienced colleagues.ResponsibilitiesFunctions:Lead risk assessments and risk management cross-functional teams (from draft to approval).Lead projects and initiatives as directed by the client, completing them autonomously using project management tools and approaches.Accountable and responsible for Tech Transfer and Gap Analysis, following up on approval flow within the electronic documentation system and facilitating all stakeholders‘ input to ensure documents are updated and approved in a timely manner internally and with the client.Develop the technical transfer plan and gap analysis of new products in collaboration with bulk, packaging, NPI QC, and quality departments.Act as a Subject Matter Expert (SME) for manufacturing topics with customers for the assigned project.Serve as the key contact for manufacturing topics related to new product introduction, collecting input from the operational team and providing feedback/input to the NPI management.Support:Support 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 operations 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 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 on approval flow within the electronic documentation system and facilitate all stakeholders‘ input to ensure documents are updated and approved in a timely manner.QualificationsExperience / Education:BS/MS in Engineering/Technical discipline or equivalent experience.10 – 15 years‘ experience in the pharmaceutical industry with a proven track record in 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 and problem-solving skills.Ability to communicate positively and persuasively.Capability to work with short deadlines and simultaneous activities.Excellent organizational and project management skills.Fluent in English and 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