Process Engineer - BPES

SUMMARY Responsible for participating in engineering design teams in the Life Science arena for this growing provider of Process Engineering and Staff Augmentation services.  Specific responsibilities include execution of engineering design projects throughout the clients design continuum.   ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties and responsibilities may be assigned as necessary. Provide world class process engineering services to our clients in the Pharmaceutical and Biotech (Life Science) industries. Participate in engineering project teams to design, review, and improve Life Science processing facilities with specific emphasis in upstream/downstream processing, purification, fill-finish and the core base utilities supporting these operations: Clean Steam (CS), Water for Injection (WFI), Clean In Place (CIP/COP), Purified Water (USP PW/RO-DI), Process Gases, etc.. Perform process simulation and studies including sizing and specification of process equipment. Perform specification and design, installation, start-up and commissioning including turnover of documentation, and validation activities. Prepare project plans for equipment and facility improvements including schedules, budgetary estimates and capital spending requests. Develop and/or modify SOP’s, specifications, drawings, equipment manuals, commission and qualification documents and maintenance procedures. Perform analysis of systems, equipment and utilities to support trouble-shooting, system diagnosis, and problem resolution of equipment and facilities. Perform all work in accordance with CPS and client applicable SOP’s, cGMP’s, corporate standards, and State/Federal laws and regulations Actively participate in sales including lead generation, presentations and proposals Successfully interface with clients, project managers, and engineering professionals Maintain relations with client technical personnel.   Represent CPS to the client on technical issues. Assist with proposal and quote development as needed by sales & marketing team. Participate with engineering and product development teams of other CPS companies to develop new products and improve current product offerings.  Assist in product development in new markets where appropriate. Work closely with engineering team on specifying CPS products with clients where possible/ethical to do so.  Keep abreast of life science industry trends and technologies.  Attend ISPE and other trainings and networking events. Attend tradeshows as requested by CPS sales & marketing. Assist in recruiting, developing and maintaining an effective engineering staff through selection, training, and motivation. Ability to interact professionally with all types and levels management. Interact professionally with customers and respond to customer needs requests in a timely and honest manner. Adhere and execute to project budgets. All other duties as required.   POSITION REQUIREMENTS To perform this job successfully, the individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   Education and Qualifications  Bachelor’s Degree in Chemical Engineering, preferred 3 years of Pharmaceutical or Biotech related process engineering experience Solid knowledge of cGMP requirements, aseptic processing (including systems and equipment) and FDA regulations   Knowledge, Skills and Experience Comfortable with all phases of the Client Design Continuum: Conceptual, schematic and detailed design of systems, including preparation of construction documents (P&IDs, flow distribution diagrams, process equipment layouts, etc.) Familiarity with ISPE Good Practice Guide and related Baseline Guides or industry standards for system design, distribution, and testing of processes systems This position requires a working knowledge of process flow diagrams, piping & instrument diagrams, mass & heat balances, basic piping system design, pump sizing, material handling methods, equipment, functional & installation specifications, as well as process instrumentation & control principles. A practical understanding of sanitary design and construction methods is preferred. This position requires strong analytical skills, basic understanding of project management fundamentals as well as strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD). Excellent verbal and written communication skills Ability to prioritize multiple projects and tasks Ability to read and interpret business periodicals, prof. journals and governmental regulations Ability to write reports and general business correspondence, and present information and respond to questions from individuals or groups   Personal Attributes Strong customer-service orientation Good organizational skills Excellent written, oral, and interpersonal communication skills – report writing, business correspondence and procedures manuals Effectively present information and field questions in a thoughtful and professional manner Maintain a calm approach when faced with disagreement or differences of opinion Highly self-motivated and directed, with a keen attention to detail Able to prioritize and execute tasks in a high-pressure environment Experience working in a team-oriented, collaborative environment Ability to maintain confidentiality of sensitive personnel information   Reasoning Ability Demonstrated ability to apply mathematical skills, interpret and analyze data and trends Ability to analyze trend data and apply logic reasoning in developing sound conclusions Demonstrated ability to extract key information in the course of decision-analysis Ability to apply trouble-shooting skills in a variety of design related situations   Physical Demands  Standing and walking are a necessary part of the job   Work Environment  Characteristics include periodic noise increases from client manufacturing processes Safety glasses and other required protection must be worn when in the manufacturing area