GSK is currently looking for a Project Engineer to join our team in Upper Merion, PA. This role will manage up to $2MM of capital across multiple projects involving commercial-scale process equipment and manufacturing suites. Responsibilities are inclusive of design, installation, qualification, and improvement of equipment and facilities in an EHS- / Regulatory- / GEP-compliant manner at the Upper Merion GSC Biopharm site.

Key Responsibilities:

• Lead and/or participate in the design and installation of new, or modifications to existing, process and/or utility systems, including bioreactors, chromatography skids, depth filtration skids, UFDF skids, etc., to meet technical, budget, and schedule goals.
• Develop a project plan and budget, and then implement the approved modifications, following up to ensure the desired result has been achieved. Document modifications in an appropriate manner. Ensure work is performed to the appropriate GxP standards, policies, and procedures. Generation, completion, & archive of various documents necessary to ensure regulator compliance, e.g. validation protocols / reports, turnover packages, drawings, etc.
• Lead discussions and recommend solutions with key customer groups in order to gain a consensus on the repair or modification plans.
• Be personally responsible for the coordination of all Engineering activities from implementation to handover to customer for a given project, including management of third party engineering firms and/or trades.
• In cooperation with the Validation Group, develop commissioning and validation documentation, including test protocols, and implement validation plans on new process and utility systems and changes to existing systems, in order to maintain the validated status of existing systems.
• Stay current with developments in the field of biopharm technology. Support the transfer of technology from development into manufacturing.
• Follow up on projects' status and arising issues/changes with all relevant parties (customer, finance, procurement and engineering departments).
• Ensure EHS corporate standards, local legislation, and other 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.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in engineering or equivalent technical discipline
• At least 2 years of prior project and/or process engineering experience in the pharmaceutical industry.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical facilities including cell culture and/or microbial fermentation, or protein recovery and purification.
• Demonstrated ability to manage projects to completion on time and within budget.
• Familiar with cGMPs, GEPs, and NIH Recombinant Guidelines for large scale biological processing. 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
• Sense of Urgency / Decision making.
• Strong interpersonal skills.
• Must be able to work within a multi-disciplinary team environment.
• Must be able to generate options to resolve problems, prioritize solutions and implement decisions. Must be competent in handling simultaneously occurring tasks and smaller projects, and have excellent written and oral communication skills.
• Good Computer Skills (MS Office, MS Projects).
• Project Management Professional Program Certification or Professional Engineer license (Preferable).

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