The Process Engineer position is responsible for determining operations to produce products and develops processes to ensure quality, cost and efficiency requirements are met. This position troubleshoots problems with production and takes corrective action. The process engineer also researches the purchase of equipment or upgrades to existing equipment. Qualified candidates need a minimum of 5 years of experience in an engineering role within the biotech/pharmaceutical industry. Design experience in areas of expertise related to these industries is a must.
Responsibilities and Duties:
Located in King of Prussia, PA, and reporting to the Operations Director – East Coast, the engineer will be responsible to support and lead the process engineering requirements for client projects.
- Develop conceptual, preliminary and detailed designs, calculations, drawings and specifications;
- Critically review engineering designs, test plans, and assess risks;
- Prepare project schedules, scope statements and budgets;
- Ensure that projects are implemented in accordance within the agreed scope and time lines and make relevant recommendations to the client;
- Work collaboratively as part of multi-disciplinary design teams;
- Chair project team meetings and provide technical direction;
- Manage timely completion of tasks per plan without direct supervision;
- Support project management requirements;
- Provide discipline specific input for bid packages and tenders;
- Suggest, contribute and champion initiatives to improve the Engineering Department’s operations and procedures;
- Support positive client interactions and sub-consultant interface;
- Perform data analysis, prepare technical reports, SOPs, and internal and external presentations;
- Pursue opportunities for business development and future growth of the organization across various local geographies.
- BS degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Industrial Engineering or related fields;
- 5 to 7 years of progressive experience in the area of process design for the biotech/pharmaceutical industry;
- Experience in the design of fluid and bulk materials handling processes including preparation of process flow diagrams, heat and material balances and P&IDs, formulation, CIP, fermentation, purification, clean utilities, biological confinement; knowledge of GMPs;
- Experience in the design of sanitary process systems including piping, vessels and CIP systems;
- Familiarity with HACCP, FDA, AIB, USIS and USDA requirements.
- PE designation or eligibility for professional registration will be considered an asset;
- Knowledge of regulatory compliance requirements;
- Strong leadership, relationship management, and organizational planning and project management skills, in addition to technical knowledge;
- Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results;
- Knowledge of post-implementation continuous improvement efforts and methodology;
- Ability to influence clients, suppliers and peers into adopting “best practices” in the engineering field;
- Excellent communication skills – verbal, written, listening and interpersonal with the ability to transfer knowledge to others;
- Capability to engage and energize others to reach their fullest potential and performance;
- Familiarity with Lean Manufacturing/Six Sigma;
- Versatility in disciplines other than the one academically trained for is highly desired;
- Proficiency in using the Microsoft Office Suite;
- Flexibility to travel to external manufacturing sites as needed.
Travel Travel is expected for this position.
N.B. It is mandatory that you reference “Process Engineer – King of Prussia, PA” in the Position field below.