Sr. Manager of Engineering and Facilities Who 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 role Reporting to the General Manager, JOB SUMMARYThe Senior Manager of Engineering and Facilities is responsible for leading a team of Engineers and third-party Facilities maintenance technicians to support 24x7 operations and growth of the business. This position is responsible for providing new equipment and maintaining suitable facilities required to support all business groups and functions operating on the Rochester site. It is the responsibility of this position to identify and lead projects for Engineering and Facilities, new works as well as Facilities maintenance. The position is also in charge of ensuring that the proper equipment are invested and installed in a timely manner following the plan to support the organization’s business goals taking into consideration the validation and qualification time. Responsibilities of the position include management and development of the team, capital, and resources.This position collaborates with other internal functional areas as the primary liaison within the Product Development organization, as well as Operations, QA and Regulatory, Business Development and global colleagues. ESSENTIAL DUTIES / RESPONSIBILITIES: Ensure budget monitoring and reporting Respect Budgetary commitment on amount and time [Committed/True/Positive] Ensure complete reporting (monitoring of projects timeline, progress, monitoring of investment commitments) to Site Management and Group as needed [Committed/True/Positive] Measure the progress of the implementation of the commitments of the operating and investment budgets and propose refocusing actions if necessary. [Reliable/Challenging/Partner]Lead industrial investment projects or works for the Site Compliant with implementation deadline, budget and procedures [Reliable/True/Partner] Study and propose technical solutions through an analysis of user needs and a technological watch and Corporate best practices [Committed/Challenging/Open-minded] Select the suppliers able to meet the needs of the project (in terms of quality, price and deadlines) based of our specifications. [True/Fair/Challenging] Respect for any new project the technical, regulatory and quality obligations issued by the Management and Quality Assurance. [Reliable/True] Control the progress of industrial projects through a reverse scheduling, a project monitoring method and the facilitation of working groups. [Committed/True/Challenging] Provide innovative and improvement solutions [Challenging/Committed] Communicates with related departments on technical data for new equipment and facilities and oversees the development and update of technical drawings in the quality documentation system. [Direct/Partner] Assist in the qualification and validation of installations and equipment by providing technical expertise in the drafting of qualification protocols and in the execution of tests. [Direct/Partner] Ensure the smooth running and technical compliance of the activities and work by coordinating the various suppliers and verifying compliance with the supplier specifications and commitments. [Committed/Direct/Partner]Oversee and develop actions to reinforce Blow-Fill-Seal capacity development Achieve deadlines, costs, regulatory compliance targets as defined in the specifications or Basis of Design [Committed/True] Participate with Management in the establishment of industrial master plans for the site, including the development of new BFS capacities. [Committed/Challenging/True] Facilitate Projects or Construction working meetings [Partner/Fair/Committed] Ensure Engineering responsibility in the Specifications, FAT, SAT process. [Direct/Curious/Reliable] Provide technical solutions in their areas of expertise. [Direct/Challenging/Partner]Successfully address technical improvement plans Manage the performance of the Engineering department by leading progression plans to identify areas for improvement, defining and following indicators and dashboards. [Committed/True] Implement critical quality CAPAs actions within established timeframes. [Committed/Partner] Propose organizational changes, adaptations, and modifications of production equipment to improve performance and reduce downtime [Committed/Challenging/Partner] Establish a training plan and provide Troubleshooting guides for critical equipment (based on data such as downtime, historical faults and issues…) to guarantee the transfert of knowledge to Production Maintenance and help them gain in autonomy. [Committed/Partner/Challenging]Manage and Develop the Team Develop team skills and autonomy to make sure the team have the appropriate skills for the projects and missions we are asking them to manage [Committed/Fair/True] Ensures processes and tools are in place to support the team [Committed/True] Develops an organizational structure that supports the retention and development of staff to deliver a high level of services, as well as offers career development for high performers/ high potentials. [Committed/Fair/True] Align and redirect priorities with the Site Management and priorities of the broader organization. [Reliable/Direct] Breaks down organizational silos and help bridge communication gaps with other departments [Partner/Curious] Engages the employees so that the team can understand how the company operates and how each person contributes to the company’s success. [Committed/Fair/Partner] Ensures an environment that encourages fresh perspectives, innovative, breakthrough ideas and new paradigms that create value in the marketplace. [Open-minded/Challenging/Partner]Your profile REQUIRED EDUCATION: Master of Engineering or Science with 10+ years of experience in a Manufacturing environment, preferably in the pharmaceutical or medical device industry, with at least 5 years in a management role. Experience in a CMO desirable.Bachelor of Engineering or Science with 14+ years of experience in a Manufacturing environment, preferably in the pharmaceutical or medical device industry; with at least 7 years in a leadership role. Experience in a CMO desirable.QUALIFICATIONS/EXPERIENCE: Manufacturing, filling, and packaging equipment and processing technology, facilities construction and maintenance.Solid understanding of pharmaceutical industry and a proven experience to bring recognized expertise to all the processes of the plant and capital construction projectsExperience in aseptic manufacturing, filling and packaging environment desiredExperienced engineering project manager with 10 years’ experienceAreas of expertise should include most, if not all of the following: GMP, FDA, regulatory affairs and compliance, quality assurance and controls, qualification, technical services… SPECIFIC SKILLS: Knowledge of a multitude of plant systems (HVAC, steam boilers, air compressors, building controls, clean rooms)Knowledge and experience on Blow-Fill-Seal (BFS) technology using Rommelag® machinesBalance the sense of urgency with adherence to all regulatory requirementsAbility to establish sound professional relationships both internally and with external partnerBuilding construction management and maintenance methods.Strong adherence to budgets, schedule, work plans and performance requirementsStrong planning and execution skills and the ability to develop a vision and lead change.Demonstrated ability to apply strategies to manage CAPEX priorities with budget constraints (Risks analysis) Record of comprehensive understanding and achievement in working in FDA and GMP regulated environmentDemonstrated ability in working effectively in a large-scale manufacturing environment with a track record of gaining buy-in from operational teams.PHYSICAL REQUIREMENTS/ENVIRONMENT: Traditional office environment, with frequent visits to other areas of the facility. Must be able to work on a computer for extended periods of time.Must wear safety glasses and other protective items as required.Sitting 75% of the day; standing or walking 25%. Ability to travel (20%)Compensation range 140,000.00 - 170,000.00 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!
