Primary responsibilities include managing the design, specification, and installation of new and renovated biopharmaceutical process equipment. This position will also provide engineering support and problem solving for existing equipment and manufacturing processes.
Summary of Essential Job Functions
Design, implement and maintain an engineering organizational structure
Provide leadership to the engineering site services associates to develop them into a highly effective maintenance and capital project team
Facilitate the implementation of local & global engineering initiatives at Fort Worth, Lausanne and Curacao and ensure that these initiatives improve the effectiveness of the engineering team and the site
Develop long term and annual capital plans which are forward looking and reflect the needs of the site
Accountable for the appropriate expenditure of funds needed to meet the needs of the business, making fiduciary decisions which span fiscal years and impacting the PCE cost related to engineering for the site
Develop, design and execute all investments safely, within the allocated budget and schedule, in compliance with all National and Local codes and standards and in adherence to Company standards and guidelines
As a member of the site leadership team support the site head in the establishment and implementation of policies and strategic directions for the overall operation
Designs and specifies cGMP process and utility equipment, piping, and controls
Works well with Quality and Regulatory to determine appropriate commissioning, validation and regulatory strategies for new or expanded facilities.
Manages projects related to process and utility equipment and manufacturing
Manages the design review, factory & site acceptance, and installation of equipment
Manages the preparation of process and instrument drawings and other related drawings.
Supports Validation Department through preparation of design documents and protocol review
Recommends appropriate corrective/preventive actions for existing equipment and manufacturing processes
Evaluates, approves, prepares and/or executes modification/change control documentation
Requires BS or higher in industrial mechanical, or civil engineering with 10+ years of experience in equipment, process, or facilities engineering. Direct experience with biopharmaceutical process equipment is strongly preferred. Other requirements include:
Thorough knowledge of cGMPs and sanitary equipment design requirements
In-depth knowledge of process control systems and automation
Advanced knowledge of engineering documentation required for cGMP process and utility equipment
Advanced knowledge of ISPE standards and FDA/EU regulations relative to facility and process
Advanced knowledge of biologic or aseptic pharmaceutical facility construction
Substantial knowledge of clean rooms and pharmaceutical equipment
Strong written and oral communication skills
Solid supervision and leadership skills
Ability to understand and manage project plans, budgets and schedules
Working knowledge of word processing, spreadsheet, and database management software;
Functional knowledge of PCs
English required; French and Spanish desirable
Healthpoint Biotherapeutics, a Smith & Nephew Business, is committed to conducting business in an ethical manner and it is our expectation that the individual in this role will ensure compliance with all applicable laws, regulations, procedures and Healthpoint’s Core Values. Healthpoint is in a highly regulated industry and, as a part of this role, this individual will be required to understand how compliance is integrated within their daily activities and perform in their role with a high level of integrity
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Healthpoint Biotherapeutics, a Smith & Nephew business, is an Equal Opportunity Employer.
Healthpoint - 21 months ago