Lead Process Engineer
: Job Details :

Lead Process EngineerWho we are?We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees. Your roleReporting to the Senior Manager, Engineering, Validation & Metrology,Guideand manage the teamEnsure the adequacy of the team's training / authorizations in relation to the department projects and tasksManage the team's schedule via ADP softwareCarry out scheduled evaluations to assess the development and performance of your teamDefine action priorities in relation to means, resources and deadlinesDevelop the skills and autonomy of the teamEnsurebudget reporting and monitoringEnsure complete reporting (project monitoring, monitoring of investment commitments, overheads) to Site ManagementMeasure progress in achieving operating and investment budget commitments and propose refocusing actions if necessary.Engagein technical discussions with potential suppliersOrganize and write specifications based on the needs and requirements Launch calls for tenders (Request for Proposal, Request for Service)Ensure the solution designed respects the established specifications(s)Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal customers are documented and validated in a formal manner.ExecuteProjects and Tasks to the approved completion deadlines and within the definedbudgetWork in partnership with external companiesPropose and apply solutions to mitigate and compensate for possible work delaysProactively alert site management to potential problemsEnsure the successful commissioning of the projectMonitorthe installations and commissioning of equipmentCoordinate the various suppliers and vendors and ensure their compliance to health and safety instructionsPossess adequate technical expertise allowing problem resolutionRespect the data in the specificationsCommunicate with Production to coordinate activities with respect to production constraints Assist with commissioning activities and in putting the equipment into productionCarry out an assessment after each commissioningServes in an expert role in writing the qualification protocol, execution of the tests and approval of any resulting report.Participatein operator training (training)Work with internal customers to define the training requirement and provide technical contentOrganize training in collaboration with suppliersStudythe technical needs associated with new site investmentsParticipate in different project groupsCollect and analyze needs from internal stakeholdersDefine technical solutions and implementationsRespect the technical, regulatory and quality requirements issued by Management and Quality Assurance.Take into account the necessary parameters (water production, energy, etc.)Respect flows, workshop ergonomics and safety constraintsEnsurethe documentation of completed projects is updatedCollect technical drawings from vendors for review and ensure they reflect the realized designCreate technical drawings of the factory and update according to approved documentation practicesSpecific Skills:This positionrequires the ability to think in high level terms to develop engineeringsolutions for new processes.It alsorequires the ability to think in specific, detailed terms when problem solvingfor existing processes.Strong background in technical troubleshooting, problem solving.Detailed knowledge of equipment operation and validation requirements.Ability to work in a matrix organization with cross-functional teamsAbility to specify, procure, oversee installation, and commission systems and processing equipment.Strong project management skills.Proficient knowledge of pharmaceutical cGMP requirements and systems a plus.Your profileREQUIRED EDUCATION: Bachelor's degree in Chemical Engineering or related discipline with equivalent experience. Master's Degree considered a plus.Associate's degree with highly relevant experience will be considered.QUALIFICATIONS/EXPERIENCE:Minimum 5 years in either a manufacturing environment, or equipment and packaging technology Experience in a regulated environment (FDA) preferredSupervisory experience a plus Hands on experience with small molecule solids and liquids manufacturing equipment a benefitExperience in sterile manufacturing preferred but not requiredCompensation range100,000.00 - 115,000.00 USD *The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. Learn more about us:We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees. Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives. We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential. We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility. Join us and make a difference!