Process Engineer II

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

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The Process Engineering (PE) department supports the three business of Birmingham Labs, DDE (Drug Delivery Services), BMA (Biomaterials), and MDCC (Medical Devices). PE is responsible for designing new processes, identifying equipment, creating/ reviewing/ approving documentation for procurement, commissioning and qualification of equipment to support business needs. PE supports troubleshooting of existing processes, investigation of deviations and continuous improvement projects. PE will provide engineering design knowledge and engineering best practice principles to all site engineers.  

RESPONSIBILITIES

Business / Operations / Customer Projects:
•    Work cross functionally with Customer Project Core team members, Maintenance / Facilities, Project Engineers, Operations teams to support internal and client funded projects.  
•    Interact and communicate effectively with internal projects teams, management, stakeholders and clients on all relevant aspects of the project.
•    Support integration of engineering activities into the overall Project Management Schedule
•    Stays fully engaged and in-tune with customer concerns and provides innovative engineering solutions to meet the project requirements.
•    Interfaces with the customer project team and equipment vendors to find the most cost efficient and robust solution to build and design the customer processes.
•    Contribute to the development of robust cost estimates for engineering projects (process design) including conceptual, basic and detailed engineering.
•    Other tasks as required
Leadership:
•    Process Engineering lead and a core team member on Client funded projects.
•    Learn and Educate site’s cross functional team members, peers and management on good engineering practices.
•    Mentor engineering interns and engineers across the site.  
•    May supervise engineering interns. 
•    Identify and contribute to projects to support site’s continuous improvement, cost control and any compliance gap remediation initiatives.  
Process Engineering:
•    Design, implement, and support new process introductions, scale-ups, and process modifications. 
•    Process design and improvement using QbD, LSS and DfSS principles (e.g. SIPOC, FMEA, criticality analysis)
•    Provide technical expertise in core process engineering disciplines (P&ID, PFD, Process Simulations, mass and energy balances, equipment sizing, selection)
•    Works with Project Engineering and uses engineering design standards in order to select robust equipment.
•    Provides equipment engineering solutions to the customer including robust and cost-effective solutions all with incorporating the customer project timeframe constraints.
•    Performs process calculations to design equipment and scale-up calculations for processes.
•    Ensures equipment and instrumentation is robustly designed to manage critical and key process parameters
•    Interfaces with the Automation Engineer on process design and control and data reporting requirements
•    Utilizes simulation tools as required for process design.
•    Incorporate sterile manufacturing principals and/or HPAPI containment requirements into process equipment design as required for specific processes.
•    Prepare supporting process documentation for projects of diverse scope and complexity.
•    Other tasks as required
Commissioning and Qualification (C&Q):
•    Support C&Q activities following ISPE’s cGEP and C&Q guidance’s and site procedures. 
•    Provides technical input to system owners in development of URS, system risk assessments, design specifications, design review, design qualification, and system TOPs.
•    Creates C&Q plan and relevant documentation (IQ/OQ, IV/OV, ECM, FSR). 
•    Executes protocols with support from system owner, project engineering, product development and facilities. 
•    Creates and maintains site engineering standards. 
•    Engages the System Owner, Quality and Validation to ensure equipment is set-up properly in the CMMS via the Equipment Action Form process. 
•    Develop and Review Preventive Maintenance checklist and/or Guidelines and Calibration specifications as appropriate.
•    Provide Technical engineering support to Validation team as required.
•    Other tasks as required
EHSSQ:
•    Ensure safety and quality is included in all process designs, discussions and decisions.
•    Ensure that Pharmaceutical Standards and cGxP’ regulations and ICH guidelines are integrated into assigned projects as appropriate.
•    Follow Environmental, Health, Safety, and Quality practices and procedures in accordance with current Local, State, and Federal Regulations.
•    Actively participate in identifying and resolving safety issues. Lead or participate in Safety risk assessments (PHA) and Quality Risk Assessments (QRA) for new process designs and process changes.
•    Participate in deviation investigations using RCA tools. Support implementation of corrective and preventive actions. 
•    Using TrackWise, support management of Deviations, Change Controls and CAPAs.
•    Support internal and external compliance audits.
•    Author and review SOPs.
•    Other tasks as required

REQUIREMENTS

•    BS/MS in an engineering field (Chemical, Bio, Biomedical Engineering preferred) with 3+ years of process engineering and design experience with a sufficiently demonstrated level of performance and capability in the completion of projects for internal and / or external customers.

• Knowledge in unit operations with parenteral drug product manufacturing

•    A demonstrated ability to do the following for engineering activities of an appropriate scope and complexity:

• Defines the scope of engineering work with internal customers.  Able to clearly define the user requirements with the customer and build-out the scope of work and collaboratively gain buy-in on the project approach.  Also develops options as it pertains to process engineering design for internal and external customers.  
• Supports the development of cost estimates and schedules and engineering solutions under the direction of engineering lead. 
• Communicates and escalates issues related to engineering design, project timing and budget with internal customers and finds creative solutions to meet their needs.

•    Capability to create and apply standard engineering procedures and techniques.
•    Ability to gain advanced knowledge of the engineering principles pertaining the operation of processing and manufacturing equipment; examples include: Reactor design, extruder design, isolators, autoclaves, filling equipment, pumps, agitator, instrumentation, data collection, bench, pilot and commercial scale operations.
•    Use technical expertise, experience, and creativity to evaluate and identify causes of unanticipated or adverse outcomes or deviations and to propose corrective action or resolutions for problems of increasing complexity.
•    Contribute to the development of novel and proprietary technologies, methods, and Intellectual Property.
•    Knowledge of the use of personal protective equipment and safety protocols and practices related to working with or exposure to hazardous chemicals that could potentially affect the health of the employee.
•    Ability to:

• Perform work utilizing a computer for extended periods of time;
• Sit for extended periods of time without being able to leave the work area;
• Stand for extended periods of time without being able to leave the work area;
• Grasp objects utilizing the fingers (fine motor manipulation);
• Reach for objects above the head or below the waist;
• Stoop or crouch by bending at the waist or by bending the legs;
• Determine colors

•    Experienced in the use of word processing, spreadsheet, and presentation software programs. 
•    Effective written and verbal communication skills; ability to clearly and effectively communicate observations, results, and outcomes to more senior technical staff.
•    A general understanding and application of relevant engineering principles, and methods; familiarity or general working knowledge of other related technical fields and applications.
•    Experience in managing smaller engineering projects as it relates to process engineering activities through the conceptual, basic and detailed engineering design phases.
•    Excellent written, verbal, and organizational skills.
•    Ability to interact and communicate effectively with senior staff, and at internal company meetings on technical aspects of experiments and research programs.
•    Conduct activities with consideration of budget, time schedules, and overall project goals and objectives.
•    Capable of independently managing engineering tasks of appropriate scope to achieve goals and objectives with consideration to budget and time schedules.
•    Actively contribute to the improvement of policy, practices, and procedures.