PTO Software Lead Engineer

Advanced Manufacturing Tech Solutions (AMTSOL)

Job Location:

Indianapolis, IN - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

About us : At AMTSOL we deliver innovation through technology for Life Sciences Manufacturing driving Pharma 4.0 and Digitalization to help regulated manufacturers accelerate speed to market ensure GxP compliance and enhance operational efficiency. With a strong presence across Singapore Europe India and the USA we specialize in end-to-end implementation and support of GMP manufacturing systems and solutions spanning Automation Manufacturing Execution Systems (MES) IT/OT Networking and Digital Technologies.

Overview: The Program Technical Office (PTO) is responsible for defining and maintaining the automation philosophy technical standards and ensuring consistency across all automation projects. During project execution the PTO provides guidance and oversight to individual project teams ensuring alignment with the overall automation strategy and compliance with regulatory and technical standards.

Key Responsibilities:

Provide technical oversight for assigned automation projects.
Work closely with project technical teams to ensure alignment with program-wide automation philosophy and standards.
Collaborate with Digital/MES workstream leads to integrate automation and digital solutions seamlessly.
Support project teams in implementing and adhering to established automation standards.
Ensure consistency and quality of automation deliverables including requirements functional specifications control strategies phases and recipes.
Define or review software components that require development or modification.
Contribute to the preparation and review of PTO deliverables.
Offer technical consulting and guidance as part of the PTO team.
Collaborate with cross-functional stakeholders to ensure deliverables meet business and regulatory needs.
Maintain compliance with required training and quality standards.

Requirements:

Bachelors degree in Engineering or equivalent experience.
10 years of automation experience in the pharmaceutical industry (preferably API or drug substance manufacturing).
Proven experience in leading or delivering large-scale automation projects.
Minimum 5 years of hands-on experience with DeltaV Batch DCS.
Minimum 3 years of experience with Allen-Bradley PLCs.
Experience with Aveva PI (OSIsoft PI) preferred.
Strong understanding of GMP regulatory requirements and computer system validation (CSV) principles.
Excellent teamwork communication and stakeholder management skills.

Key Responsibilities:

Provide technical oversight for assigned automation projects.
Work closely with project technical teams to ensure alignment with program-wide automation philosophy and standards.
Collaborate with Digital/MES workstream leads to integrate automation and digital solutions seamlessly.
Support project teams in implementing and adhering to established automation standards.
Ensure consistency and quality of automation deliverables including requirements functional specifications control strategies phases and recipes.
Define or review software components that require development or modification.
Contribute to the preparation and review of PTO deliverables.
Offer technical consulting and guidance as part of the PTO team.
Collaborate with cross-functional stakeholders to ensure deliverables meet business and regulatory needs.
Maintain compliance with required training and quality standards.

Requirements:

Bachelors degree in Engineering or equivalent experience.
10 years of automation experience in the pharmaceutical industry (preferably API or drug substance manufacturing).
Proven experience in leading or delivering large-scale automation projects.
Minimum 5 years of hands-on experience with DeltaV Batch DCS.
Minimum 3 years of experience with Allen-Bradley PLCs.
Experience with Aveva PI (OSIsoft PI) preferred.
Strong understanding of GMP regulatory requirements and computer system validation (CSV) principles.
Excellent teamwork communication and stakeholder management skills.