Automation Engineer, Project Manager
Greater Boston Area
Tech USA is currently seeking an Automation Engineer/ Project Manager to join a dynamic and diverse engineering team with an industry leading company. We are looking for an energetic, team oriented, and motivated professional, who will perform well in a fast paced environment. The ideal candidate will have experience doing this within the Bio or Pharma industries, coupled with at least 10 years industry experience.
This position is responsible for management of the entire project life cycle of the automation of newly fabricated process equipment on an Emerson DeltaV process control system.
This position supports manufacturing by working with other groups to identify process control gaps and rectify them through an approved change control process. The goal for this position is to interface with multiple stakeholders and manage the integrator to meet the user’s requirements.
- Participate in the RFP process, technical evaluation of bids and award of a service contract to a system integrator.
- Manage the automation contractor in its further development of Functional Specifications, software and hardware design, and writing and testing of software code.
- Interface with the Engineering Lead and AE Lead to implement a design aligned with Genzyme site requirements.
- Develop appropriate metrics; measure and report on progress of project deliverables.
- Maintain an automation schedule, and manage to it.
- Understand and manage the CQV process with respect to automation, including FAT and SAT protocols and Automation CTPs
- Have an understanding of the translation of manufacturing process information into the design of control systems that will be utilized by equipment systems employed in the manufacture of biological products.
- Must have the ability to independently support process changes and improvements with regards to software changes as well as instrumentation and equipment troubleshooting.
- Ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain good communication between departments is essential.
SKILLS & QUALIFICATIONS:
- Bachelor’s degree in Engineering, Computer, Science or related technological field
- 10+ years of relevant work experience with 7+ years’ experience in operations/manufacturing environment.
- Demonstrated project management skills.
- Experience with DeltaV or similar process control system
- General understanding of GMPs. Able to interpret CFRs in establishing current practices.
- Direct experience within regulated environments (i.e. cGMP, OSHA, EPA).
- Working knowledge of Pharmaceutical/Biotech processes
- Strong understanding of Quality systems
- General understanding and wide application of technical principle, theories, and concepts in pharmaceutical/biotech field.
- Demonstrated skills in the following areas:
- Problem solving and applied engineering.
- Basic technical report writing
- Verbal communication
- Technical presentations
- Personal Organization
- Dealing with and managing change
- Some Demonstrated Skills in the following areas:
- Strong project management skills. Manage external resources.
- Experience with process Instrumentation including Fieldbus, ASi bus, and DeviceNet.
- Experience with GAMP
- Ability to effectively and appropriately escalate operational issues
- Experienced in establishment of safe practices in a CGMP environment
About Tech USA:
Tech USA, Scientific Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further.
At Tech USA we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job. As a result, Tech USA is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. Tech USA is an equal opportunity employer.