TECHNOLOGY SERVICES PRINCIPAL SCIENTIST

AstraZeneca•Canóvanas, PR

About The Position

Responsible for supporting, implementing and sustaining technology platforms, ensuring reliability, scalability, and cost effective operations. The role owns and serves as a SME for executing the strategy, operational excellence, budget management, and stakeholder engagement initiatives across multiple business units. This leader drives continuous improvement and transformation initiatives, aligns services to business outcomes Among the scope of the role, includes research of the best business practices within and outside the organization to establish benchmark data. Collects and analyzes process data to initiate, develop and recommend business practices and procedures that focus on improved programs quality, increased efficiency and reduced cost including automation/digitazation. Co leads GMP programs such as qualifications/validations, CPV, APR among others. Typical Accountabilities Develop and co lead the strategic planning for the site (e.g. 5-year plan), including areas for LTO, innovation, process improvements, resources planning and business case justification. Coordinate and facilitate department meetings and/or Kaizen events that drive process improvements. Develop, manage and monitor department execution and cost monitoring (budget, RBU, accruals, etc). vs. plan on a monthly basis, as required. Leads or co-leads, manage or provide support to projects and initiatives that may include business case preparation, planning, execution and monitoring projects/initiatives from concepts through implementation. Co leads the preparation of annual budget and MTP forecast, including financial cost monitoring adherence on a monthly base for expenditure and capital revenue for corresponding BU within Engineering Department. Effectively manages changes to project/programme scopes. Establishes relationships with business stakeholders (internal/external) to gather business requirements and ensure their understanding and commitment to the project/programme objectives. Influence stakeholders and extended project team for keeping focus when unplanned situations arise. Provides support to the departments by gathering and analyzing data in the establishment and/or maintenance of corporate business processes, procedures and policies. Prepares presentation for management reports and implements online management reports and key performance parameters. Evaluates and monitors the performance and efficiency of programs to ensure the implementation are on target and in compliance, especially on areas where the individual serves as an SME such as SAP, PBI dashboards, ALCM, TPM and others. Assists with the preparation of a variety of documents such as Business Case, CAS generation, routing/approval, internal order, asset creation, procurement process (PO’s, contracts, SE’s etc.), reports covering budget status, forecast reports and other management reports. Provides technical expertise and support to the generation of regulatory documentation, including complex investigations and tech transfers for market access or material qualifications. Identify and ensure equipment qualifications, computer systems validations and process validations including cleaning validations that are required to manufacture current and/or future TT products/market access/divestments. This includes equipment qualifications from IQ, OQ, IOQ and computer validation cycles to PPQ and all SOP documents related to establishing the equipment or technology (process validation). Identify, evaluate, source and implement key technology initiatives to improve productivity and compliance, along with supporting other business units and functions to deliver their functional strategy (e.g. laboratories, Warehouses, FUME-GMP equipment) and Security/SHE areas. Supports all aspects of a project, including, but not limited to new technology acquisition, new product/package introduction, process development and optimization.

Requirements

Bachelor’s degree in chemical, Electrical, Computer or Mechanical Engineering or other Sciences and minimum of seven (7) years related experience and/or training.
Thorough knowledge of the pharmaceutical industry with emphasis in manufacturing, packaging, utilities, infrastructure and related equipments (including automation).
Experience managing personnel preferred.
Fully Bilingual (English and Spanish)
Ability to read, analyze, and interpret general business (Business acumen), professional industry trend, including SHE area /technical/GMP and government regulations.
Ability to write business case project proposals, plans, budgets and relate project documents.
Ability to write technical (both high and low level) specifications, procedures, plan, and reports.
Ability to effectively present technical information and respond to questions from group of peers, managers, and customers/stakeholders.
Working knowledge of MS Windows Operating Systems. Windows applications such as Word, Excel, Access, Power Point and Project, among others.
Working knowledge on SAP.
Basic knowledge of statistics.

Responsibilities

Develop and co lead the strategic planning for the site (e.g. 5-year plan), including areas for LTO, innovation, process improvements, resources planning and business case justification.
Coordinate and facilitate department meetings and/or Kaizen events that drive process improvements.
Develop, manage and monitor department execution and cost monitoring (budget, RBU, accruals, etc). vs. plan on a monthly basis, as required.
Leads or co-leads, manage or provide support to projects and initiatives that may include business case preparation, planning, execution and monitoring projects/initiatives from concepts through implementation.
Co leads the preparation of annual budget and MTP forecast, including financial cost monitoring adherence on a monthly base for expenditure and capital revenue for corresponding BU within Engineering Department.
Effectively manages changes to project/programme scopes.
Establishes relationships with business stakeholders (internal/external) to gather business requirements and ensure their understanding and commitment to the project/programme objectives. Influence stakeholders and extended project team for keeping focus when unplanned situations arise.
Provides support to the departments by gathering and analyzing data in the establishment and/or maintenance of corporate business processes, procedures and policies.
Prepares presentation for management reports and implements online management reports and key performance parameters.
Evaluates and monitors the performance and efficiency of programs to ensure the implementation are on target and in compliance, especially on areas where the individual serves as an SME such as SAP, PBI dashboards, ALCM, TPM and others.
Assists with the preparation of a variety of documents such as Business Case, CAS generation, routing/approval, internal order, asset creation, procurement process (PO’s, contracts, SE’s etc.), reports covering budget status, forecast reports and other management reports.
Provides technical expertise and support to the generation of regulatory documentation, including complex investigations and tech transfers for market access or material qualifications.
Identify and ensure equipment qualifications, computer systems validations and process validations including cleaning validations that are required to manufacture current and/or future TT products/market access/divestments. This includes equipment qualifications from IQ, OQ, IOQ and computer validation cycles to PPQ and all SOP documents related to establishing the equipment or technology (process validation).
Identify, evaluate, source and implement key technology initiatives to improve productivity and compliance, along with supporting other business units and functions to deliver their functional strategy (e.g. laboratories, Warehouses, FUME-GMP equipment) and Security/SHE areas.
Supports all aspects of a project, including, but not limited to new technology acquisition, new product/package introduction, process development and optimization.