Manufacturing IT Solutions Architect

Job Title: Manufacturing IT Solutions Architect / IT SME for MES-EBMR System & Technical Support

Job Location: Bangalore

Reporting to: IT Lead for MES-EBMR Systems

About Syngene : Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures practices and systems that ensures safe operations and compliance to companys integrity & quality standards
• Driving a corporate culture that promotes environment health and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self teams and lab/plant by adhering to safety protocols and following environment health and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrityhealth and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times.

Core Purpose of the Role:

As the IT Subject Matter Expert (SME) for MES (Manufacturing Execution System) and Technical Support Systems in the pharmaceutical industry you will be responsible for providing expertise and support for these critical systems. Your role will involve ensuring the efficient operation of the MES system and providing technical support to end-users. You will collaborate with cross-functional teams to optimize system performance implement enhancements and ensure compliance with industry regulations.

Key Responsibilities:

1. Serve as the primary point of contact and subject matter expert for the MES system and technical support systems.
2. Provide technical support and troubleshooting for end-users ensuring timely resolution of system-related issues.
3. Responsible for support of MES integration - L2 integration with multiple systems parts of MES Implementation (Weighing Dispensing SAP QMS & DMS integration)
4. Participate in system validation activities including documentation testing and change management processes to ensure compliance with regulatory standards.
5. Develop and deliver training programs for end-users to maximize their proficiency in utilizing the MES system and technical support systems.
6. Assist in the evaluation and selection of new systems or upgrades ensuring compatibility and integration with existing IT infrastructure.
7. Collaborate with cross-functional teams to define and implement standard operating procedures and best practices for system usage.
8. Develop and implement computer system validation strategies policies and procedures in alignment with regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Technical and Leadership skills:

• In-depth knowledge and expertise in MES systems such as Werum PAS-X Syncade or similar platforms and technical support systems commonly used in the pharmaceutical industry.
• Proficiency in troubleshooting system issues analyzing system performance and implementing system enhancements.
• Excellent communication skills to effectively collaborate with cross-functional teams end-users and vendors.
• In-depth knowledge of computer system validation principles methodologies and regulatory guidelines such as GAMP 5 and FDA regulations.
• Strong analytical and problem-solving skills to assess validation risks and develop effective mitigation strategies.
• Excellent communication and interpersonal skills to collaborate with stakeholders at all levels including IT professionals system owners and regulatory agencies.
• Leadership abilities to guide and influence project teams and stakeholders in the validation process.
• Detail-oriented mindset with the ability to review and approve validation documentation accurately.
• Knowledge on data backup restore for GxP instruments.
• Must have experience handling Internal Audit and external regulatory Audits FDA Audit coordinates with team support MES-related information and compliance towards 21 CFR part 11.

Qualification & Experience:

• Bachelors degree in Information Technology Computer Science Engineering or a related field.
• Extensive experience working with MES systems and technical support systems in the pharmaceutical industry.
• Solid understanding of manufacturing processes quality systems and regulatory compliance requirements in a pharmaceutical manufacturing environment.
• Proven experience in providing technical support and troubleshooting for MES systems and technical support systems.
• Strong knowledge of system validation processes documentation and change management in a regulated environment.
• Familiarity with quality management systems (QMS) and good documentation practices (GDP).
• Experience with regulatory inspections and audits related to computer system validation.
• Strong written and verbal communication skills.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodation for qualified individuals with disabilities.