ViTalent Consulting Group is a premier professional services organization that specializes in engineering and technical services consulting for life sciences. Our mission is to impact lives as a long term partner for both talent and organizations.
We are currently seeking an
Automation Area Lead to support a long term project involving the construction of multiple standalone, highly flexible GMP clinical trial drug substance facilities on a greenfield site. The scope includes site infrastructure, utilities, administrative offices, laboratories, and warehousing. These facilities will be designed to support the production of drug substances for small molecules, biologics, and nucleic acid therapies.
This is a hybrid position requiring at least one week per month onsite in Indiana during the design and build phases, and full-time onsite presence during commissioning
The
Automation Area Lead will be responsible for the control system solution for an area within a capital project, ensuring the solution is aligned with the overall program automation philosophy, standards and user requirements. The area lead will work in conjunction with the other members of the Project Team, including the Automation Project Manager, Automation Technical Lead, Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.
Role Responsibilities: - Technical ownership for an area in a project
- Define the S88 software structure and list for the area
- Develop draft function design specifications for the area
- Work with system integrators to finalize the functional specifications
- Participate in P&ID and control strategy reviews
- Work closely with the Project Technical Lead and System Integrator to successfully deliver the project on schedule and budget
- Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards
- Ensure consistency of the automation deliverables in the area (requirements, functional specifications, control strategies, phases, and recipes, etc.)
- Assist in defining the software components that need to be created or modified
- Communicate progress, issues, and needs to automation technical lead for the project
- Provide input, review, and approve functional requirements and specifications
- Develop Parameter and Recipe Specification documents
- Respond to system integrator technical queries
- Identify of any remediation effort required on process control software
- Create items in the issue tracker as issues arise after the software acceptance
- Identify and analyze risks of technical nature particular to the area and planning responses
Role Requirements: - BS Engineering (or equivalent experience)
- 8+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing)
- Previous Pharmaceutical Automation Large Project/Program experience/expertise
- 5+ years' experience in DeltaV Batch DCS
- Previous experience with Allen-Bradley PLCs preferred
- Strong knowledge of GMP's, regulatory requirements and computer system validation principles
- Excellent written and verbal communication skills for both technical and non-technical audiences
- Strong knowledge of GMP's, regulatory requirements and computer system validation principles
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.
Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Interested, qualified candidates please complete the online application. We look forward to getting to know you as you consider next steps in your career.