- Ensure efficient operation, maintenance and upkeep of Plant Equipment and Utilities.
- Maintain, improve and keep updated all Engineering Documents and records
- Ensure compliance to Quality, Safety and Regulatory requirements.
- Ensure compliance of SOPs, cGMP practices along with good documentation and record keeping.
- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
- Ensure timely execution of preventive and breakdown maintenance as per SOP..
- Maximizing plant uptime by keeping track of OEE & breakdown reports.
- Meet internal customer expectations on costs and quality deliverables
- Foster a disciplined, inclusive, and transparent work environment promoting fairness and collaboration.
- Control engineering costs within approved and sanctioned budget limits.
- Ensure uninterrupted utility services to plant to achieve targeted production.
- Identify energy conservation opportunities and lead energy-saving projects and initiatives.
- Approve engineering purchase requisitions in the SAP system.
- Review and approve engineering challans and vendor bills.
- Ensure execution and timely completion of various projects.
- Monitor & control the Engineering CAPEX and OPEX budget.
- Lead cost optimization and de-bottlenecking initiatives.
- Actively participate in ERP implementation, refurbishments, and facility modification projects.
- Periodically review and update departmental SOPs.
- Stay updated with regulatory guidelines (USFDA, MHRA, MCC, MCA, etc.) and train team members on new requirements.
- Participate in bilateral discussions, including wage settlements and labor-related matters.
- Perform duties of the Management Representative (MR) for the EHS Management System.
- Ensure effective implementation of EHS systems as per ISO 14001:2015 and ISO 45001:2018 standards.
- Actively participate in ISO 14001, ISO 45001, ISO 13485 audits, and Management Review Meetings.
- Ensure compliance with regulatory requirements from agencies such as USFDA, EU, TGA, MHRA, ANVISA, WHO, and Schedule M.
- Participate in validation activities as per the protocol.
- Review of various RFPs (Request for Proposal) from customer and preparing Gap analysis.
- Lead budget preparation and manpower planning, including CAPEX and OPEX finalization.
- Prepare capital investment proposals for new products and facility modifications..
- Ensure knowledge and involvement in SFTI and conduct periodic reviews of AET team performance.
- Counsel employees on discipline, productivity, quality, and system deviations; issue advisory/warning letters through HOD and HR.
- Set KRA for reportees and monitor the progress. Give periodic feedback regarding performance and guide whenever necessary.
- Support the Accounts team in preparing cost sheets for new and potential business projects.
- Identify training needs and coordinate with HR for execution of development programs.
- Review and approve Change Controls, Deviations, and CAPAs in the electronic quality management system.
Qualifications
Graduate/Post Graduate in Engineering with technical experience.
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Pharma Solutions (PPS)
is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
