Senior Manager-Instrumentation

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Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end\-to\-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process \& Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider \& experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Manager\-Instrumentation

Job Description

• Maintain and troubleshoot instrumentation and automation systems (preventive and breakdown) for process and utility equipment, including PLC/SCADA/DCS and fire alarm systems.
• Manage calibration and compliance programs for instruments, weighing balances, and standard weights; ensure schedules are met and SOPs remain current.
• Ensure adherence to GMP, QMS, EHS, and regulatory requirements, including 21 CFR Part 11 compliance for automation projects.
• Own instrumentation documentation and deviation management, including root\-cause analysis and audit readiness/closure support.
• Plan and coordinate plant instrumentation engineering activities to support production targets, operational excellence, and cost effectiveness.
• Support projects and modifications by coordinating with project/user departments and completing required documentation.
• Control spend by tracking budget vs. actuals, preparing annual budgets, and verifying vendor bills against ARC/quotations.
• Maintain critical spares inventory to minimize downtime and improve maintenance efficiency.
• Develop team capability through guiding/training subordinates and training user departments on instrumentation systems.

1\. Responsible for Preventive and Breakdown Maintenance of Process Equipment and Utility Equipment Instruments, PLCs, SCADA, DCS \& Fire alarm systems.

2\. Responsible for online GMP documentation for the Instrumentation team.

3\. Responsible for statutory compliance of the weighing balances and standard weights.

4\. Verification of vendor bills as per ARC/Quotation.

5\. Responsible for deviation handling with respect to instrumentation and to identify the root cause by using root cause analysis tools.

6\. To plan, organize and monitor all Instrumentation related engineering activities in the plant to meet the production targets in a most cost effective manner with the operational excellence culture.

7\. Ensure that all Calibration activities are completed within the scheduled time lines and adherent to calibration policy. To ensure all the SOPs are current and are in use by the concerned personnel.

8\. Co\-ordinate with project department to stay upbeat on the current projects and extend support for documentation as and when required.

9\. Ensure the Instrumentation systems to meet all QMS, EHS and regulatory requirements.

10\. Introduce technological change for improved Quality, GMP \& Safety and cost effectiveness.

11\. To fulfil the needs of modification activities as per the user requirement along with related documentation.

12\. Tracking Budget Vs Actual expenditure. Prepare yearly budgets and Work services to meet targeted requirements and controls.

13\. Ensure the preparation of Calibration schedules, Preventive maintenance schedules and shift schedules of Man power.

14\. Optimize and maintain the critical spares inventory required to reduce the production downtime and simplifies equipment maintenance.

15\. Create the QMS culture within the department and ensure QMS requirements are understood and being followed to bring improvements.

16\. Responsible to face Quality, EHS Audits independently. Audit readiness during the audits and comply the QMS requirements and there by continuous improvement.

17\. Ensure the compliance of EHS policies during the work and promote occupational health and safety through proper handling of maintenance activities to achieve accident free work environment.

18\. Guiding and training the subordinates in their respective areas.

19\. Provide the training to user departments on Instrumentation systems to smoothen the production activities.

20\. Ensure 21 CFR Part\- 11 compliance in all types of automation projects.