Senior Manager Engineering - MTS

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

The Sr. Manager Process Engineering of Manufacturing Technologies and Sciences (MTS), reports to the Director-MTS, and is responsible for providing leadership, technical management, and professional development for the MTS Engineering team as well as collaborating between MTS Process Specialists Team, MTS management, Project Management, Process Development, Purchasing, Validation, Quality, Safety & Manufacturing teams.  A major responsibility for the Sr. Manager is to provide technical support and strategic direction to internal stakeholders and external clients, providing guidance to technical writing and decision making in the execution of the specific client project deliverables, all performed in a timely manner. The Sr. Managers’ actions support overseeing of Process Engineering into PCI manufacturing, plant floor operations (formulation/fill/finish/lyophilization), and development of manufacturing documentation supporting new product introduction. 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Lead and manage the Process Engineering team within MTS, including hiring, training, and development of team members to ensure a high-performing and collaborative workforce.

• Manage team to support the planning and execution of tech transfer/new product introduction projects with operational and validation support by working in cross-functional teams (such as development, engineering, facilities, manufacturing, quality, etc).

• Support complex/challenging processes with unique equipment, componentry, processing requirements (e.g. PUPSIT, containment, low O2), etc.

• Manage team to Identify and Implement new technologies and methodologies within the MTS function, staying abreast of industry trends and best practices while driving continuous improvement.

• Design/Review/Approve engineering drawings (i.e. Single use components, assemblies, PFDs, etc) for completeness, accuracy, and compliance with relevant standards and regulations. 

• Develop and execute comprehensive technical transfer plans, including requirements, risk assessments, and mitigation strategies, to ensure successful transfer of processes to manufacturing sites.

• Support process characterization studies, process validation activities, and risk assessments to ensure robustness and compliance of transferred processes at commercial scale

• Support resolution of complex manufacturing issues and provide technical support of critical process-related deviations in terms of root cause investigations and implementation of robust corrective or preventative actions.

• Manage/Support the technology transfer of processes from internal and external development groups, efficiently assessing risks to project objectives, reducing risk through collaborative studies, and supporting manufacturing engineering runs and cGMP lots

• Provide technical leadership and guidance to both internal and external requirements for defining scope, planning, scheduling resources and overseeing the MTS project support activities according to business proposals and site/client’s requirements.

• Provide technical perspective during internal and external audits, regulatory inspections and due diligence as appropriate.

• Facilitate tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business

• Interface directly with all clients to ensure highest level of customer satisfaction is achieved.

• Demonstrate and promote continuous improvement in efficiency, quality, and safety through technical development, job knowledge, education and training.  Implementation of associated changes utilizing various quality systems as necessary.

• Remain current with biopharmaceutical industry best practices, technologies and developments in their respective specialization or practice by a