- Lead in the business analysis, feasibility, and conceptual design of new or modifications to existing (bio)pharmaceutical processes of medicines and vaccines - including bioreactors/fermenters, chromatography, filtration skids, formulation, and filling to meet technical, budget, and schedule goals. Contract with strategy and manufacturing sites to develop project objectives and develop plans to progress designs and funding to deliver and define projects. Draft project plans, define budgets, define schedules to implement. Consult on process designs, equipment selection, procurement methods, quality implications, and then implement the approved modifications.
- Knowledge of current engineering services market offerings and practices to ensure effective engagement and understanding. Knowledge of cGMP and market trends in automation, validation, construction to ensure project execution excellence and continuous improvement. Knowledge of benchmark costs and durations to effectively plan projects.
- Lead discussions and recommend solutions with key customer groups in order to gain a consensus on objectives, scoping, options for implementation, and effectively negotiate changes. Follow up on projects' status and arising issues/changes with all relevant parties (customer, finance, procurement and engineering departments).
- Be personally responsible for the coordination of all engineering activities and interactions with engineering, equipment, and construction firms over the various phases of project lifecycle.
- Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation. Apply corporate EHS standards related to employee's safety during construction/ demolition processes to achieve zero reportable injury rate, with continuous supervision and control on contractors' activities.
- BS degree in engineering or equivalent technical discipline
- At least 8 years of prior project and/or process engineering experience in the pharmaceutical industry.
- MBA, Masters in Engineering, and/or Professional Engineer
- At least 15 years of prior project and/or process engineering experience in the pharmaceutical industry is preferred.
- Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities.
- Demonstrated ability to manage projects > $10m to completion on time and within budget (minimum), preference for > $50m.
- Familiar with cGMPs, GEPs.
- Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities.
- Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.
- Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.
- Must be comfortable and thrive in ambiguity and think strategically to solve complex problems.
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Engineering Design Manager - Rockville, United States - 1925 GlaxoSmithKline LLC
Description
GSK is currently looking for an Engineering Design Manager to join our team. This role will manage the front-end engineering of large and/or complex capital projects of value > $10m. Front end engineering includes determining business objectives, identifying process technology and delivery strategies, providing project definition, and owning the technical delivery and project management through its governance. Responsibilities are by first intent for projects executed within the US, but could support global projects as team portfolio evolves. Fluency in (bio)pharmaceutical processes, facilities, operations, market developments, engineering methods, and GSK standards in project management, operations, quality, and EHS are essential.
Key Responsibilities:
Basic Qualifications:
Preferred Qualifications:
#LI-GSK
Please visit to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
