What are the responsibilities and job description for the Project Technical Lead – Development Laboratory and Support Areas position at ViTalent?
ViTalent Consulting Group is a premier professional services organization specializing in talent acquisition, talent development, staffing, and consulting for the Life Sciences industry. Our business is people! With talent in high demand, our mission is simple: to impact lives as a long-term partner for both talent and organizations.
We are currently seeking a Project Technical Lead - Development Laboratory and Support Areas for a long term project involving the construction of multiple standalone, highly flexible GMP clinical trial drug substance facilities on a greenfield site. The scope also 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. The project is currently in the Basic Engineering design phase.
The Automation Program is in development and is in the process of being staffed. It will consist of multiple independent Automation Project Teams, each assigned to a specific facility and operating under the oversight of a central Automation Program Office. Each Automation Project Team will include an Automation Project Manager, a Technical Lead, and several Automation Area Leads. Together, they will define the Automation Hardware and Software Requirements, Standards, and Best Practices. These teams will also engage and oversee System Integrators responsible for detailed automation design, coding, and testing.
Purpose of the Role:
The Technical Lead will be responsible for technically leading the Automation control system solution for the Development Laboratory and automation interfaces to support areas e.g Warehouse and Administration areas. They will work closely and in conjunction with the other members of the Project Team, including the Automation Project Manager, the Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.
Role Responsibilities:
Applicants must be authorized to work for any employer in the United States without visa sponsorship. ViTalent Consulting Group is unable to sponsor or take over sponsorship of an employment visa.
If you have interest and meet the qualifications, please apply online via this posting or at https://www.vitalent.com/. We look forward to getting to know you as you consider next steps in your career.
#VTLS
We are currently seeking a Project Technical Lead - Development Laboratory and Support Areas for a long term project involving the construction of multiple standalone, highly flexible GMP clinical trial drug substance facilities on a greenfield site. The scope also 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. The project is currently in the Basic Engineering design phase.
The Automation Program is in development and is in the process of being staffed. It will consist of multiple independent Automation Project Teams, each assigned to a specific facility and operating under the oversight of a central Automation Program Office. Each Automation Project Team will include an Automation Project Manager, a Technical Lead, and several Automation Area Leads. Together, they will define the Automation Hardware and Software Requirements, Standards, and Best Practices. These teams will also engage and oversee System Integrators responsible for detailed automation design, coding, and testing.
Purpose of the Role:
The Technical Lead will be responsible for technically leading the Automation control system solution for the Development Laboratory and automation interfaces to support areas e.g Warehouse and Administration areas. They will work closely and in conjunction with the other members of the Project Team, including the Automation Project Manager, the Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.
Role Responsibilities:
- Technical ownership for the Development Laboratory and Support Areas project
- Technical management of the Development Laboratory and Support Areas project system integrator(s)
- Working closely with the Development Laboratory and Support Areas Automation Project Manager 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
- Collaborate with their Digital/MES workstream counterpart leads to align the automation and digital solutions
- Provide technical leadership to the multiple area leads working on their project for the respective area and ensure that applicable standards are followed
- Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies etc.)
- Participate in P&ID and control strategy reviews
- Assist in defining the software components that need to be created or modified
- Communicate progress, issues, and needs to automation project manager for the area
- Provide input, review, and approve functional requirements and specifications
- Responding to system integrator technical queries
- Support the development of software testing strategies
- Identification 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
- Maintain compliance with training requirements
- BS Engineering (or equivalent experience)
- 10 years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing)
- Previous Development Laboratory project or site experience
- Previous Pharmaceutical Automation Large Project/Program experience/expertise
- Experience with devices integration into automation and historian platforms
- Preferable, a previous experience with DeltaV DCS
- Exceptional teamwork abilities
- 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
- Excellent written and verbal communication skills for both technical and non-technical audiences
Applicants must be authorized to work for any employer in the United States without visa sponsorship. ViTalent Consulting Group is unable to sponsor or take over sponsorship of an employment visa.
If you have interest and meet the qualifications, please apply online via this posting or at https://www.vitalent.com/. We look forward to getting to know you as you consider next steps in your career.
#VTLS
