What are the responsibilities and job description for the Small Molecule Project Technical Lead position at ASM Tech Solutions?
Duration: Desired Duration is 3 years (Full Time, On-Site)
Purpose Of The Role
The Small Molecule Technical Lead will be responsible for technically leading the Automation control system solution for the Small Molecule facility. They will work closely and in conjunction with other members of the Small Molecule facility Project Team, including the Automation Project Manager, the Automation Area Leads, Process Engineers, Tech Services/Manufacturing Science Representatives, Quality Engineers, and Operations.
Role Responsibilities
Purpose Of The Role
The Small Molecule Technical Lead will be responsible for technically leading the Automation control system solution for the Small Molecule facility. They will work closely and in conjunction with other members of the Small Molecule facility 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 Small Molecule project
- Technical management of the Small Molecule project system integrator
- Work closely with the Small Molecule 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 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 applicable standards are followed
- Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies, phases, recipes, 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
- Support the creation of Parameter and Recipe Specification documents
- Respond to system integrator technical queries
- Support the development of software testing strategies
- Identify 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 plan responses
- Maintain compliance with training requirements
- BS in Engineering (or equivalent experience)
- 10 years of working automation experience in the Pharmaceutical Industry (preferably in API/bulk manufacturing)
- Previous Small Molecule Manufacturing project or site experience
- Previous Pharmaceutical Automation Large Project/Program experience/expertise
- 7 years' experience in DeltaV Batch DCS
- Preferably previous experience with Allen-Bradley PLCs
- Exceptional teamwork abilities
- Strong knowledge of GMPs, regulatory requirements, and computer system validation principles
- Excellent written and verbal communication skills for both technical and non-technical audiences