Senior Pharmaceutical Manufacturing Systems Manager

1 week ago

Nagpur, Maharashtra, India beBeeManufacturing Full time ₹ 20,00,000 - ₹ 25,00,000
Job Description

The role of a Manufacturing Execution System (MES) Implementation and Validation Lead is to oversee the successful deployment and validation of MES systems within pharmaceutical manufacturing sites.

This position requires strong technical knowledge of MES platforms, as well as experience in leading site-level validation activities and managing GxP documentation.

The ideal candidate will ensure adherence to global regulations, including FDA 21 CFR Part 11 and EU GMP, while maintaining a high level of attention to detail and compliance mindset.

  • MES Design and Configuration: Representing site-specific needs during MES design and configuration.
  • Validation Leadership: Leading IQ, OQ, PQ, UAT, and traceability matrix execution.
  • Documentation Management: Managing GxP documentation, including URS, FS, DS, test cases, and validation plans/reports.
  • MES Product Expertise: Maintaining deep knowledge of MES functionality and architecture.
  • Front-End Support: Acting as the first point of contact for MES application issues and user support.
  • Training and Adoption: Delivering training and ensuring user readiness for MES usage.
  • Data Management: Supporting data collection, migration, and master recipe creation.

Requirements:

  • Bachelor's degree in Engineering - Information Technology, Computer Science, Production, Pharmaceutical Sciences, or a related technical field.
  • Preferred: Master's degree with specialization in Industrial Automation, Pharmaceutical Technology, or related technical fields.
  • GAMP 5 for system validation in regulated environments.
  • CSV (Computer System Validation) for compliance with GxP.
  • MES Platform Certifications e.g., Werum PAS-X, Siemens Opcenter, or Rockwell.
  • 21 CFR Part 11 Compliance Training for electronic records and signatures.

Experience:

  • 6 to 8 years of experience.
  • Pharmaceutical Manufacturing: Strong understanding of pharma shop floor operations and regulatory requirements.
  • MES or Digital Systems: Prior hands-on experience with MES platforms or similar systems in GxP-regulated environments.
  • Validation Expertise: Proven experience in validation documentation and execution, especially for GxP Category 4 & 5 systems.
  • Application Support: Experience in resolving front-end MES issues and supporting end-users post-deployment.
  • Audit Experience: Familiarity with audit processes and documentation expectations.

Skill (Functional & Behavioural):

  • Functional: MES system configuration, deployment, and validation, Front-end application troubleshooting and user support, GxP and 21 CFR Part 11 compliance, Validation protocol development and execution (IQ, OQ, PQ, UAT), Documentation management (URS, FS, DS, traceability matrices), Data migration and master recipe creation.
  • Behavioral: Strong communication and interpersonal skills, Proactive problem-solving and risk management, High attention to detail and compliance mindset, Ability to work under pressure and manage multiple priorities, Detail-oriented with a focus on compliance and quality, Proactive problem-solving and decision-making, Comfortable working on the shop floor and in technical environments.

  • Pharmaceutical Medical Representative

    3 weeks ago

    Nagpur, Maharashtra, India Deshbhakt Pharmaceutical Pvt Ltd Full time

    Designation - Pharma Medical RepresentativeLocation - Nagpur / NandedSalary - Hike on your current salaryRole DescriptionThis is a full-time on-site role for a Pharmaceutical Medical Representative, located in Nagpur . The primary responsibilities of the Medical Representative include promoting and selling pharmaceutical products to healthcare professionals,...

  • Pharmaceutical Medical Representative

    3 weeks ago

    Nagpur, Maharashtra, India Deshbhakt Pharmaceutical Pvt Ltd Full time

    Designation - Pharma Medical RepresentativeLocation - Nagpur / NandedSalary - Hike on your current salaryRole DescriptionThis is a full-time on-site role for a Pharmaceutical Medical Representative, located in Nagpur . The primary responsibilities of the Medical Representative include promoting and selling pharmaceutical products to healthcare professionals,...

  • Pharmaceutical Procurement Expert

    2 weeks ago

    Nagpur, Maharashtra, India beBeePharmaceutical Full time ₹ 5,00,000 - ₹ 9,00,000

    Procurement Leadership PositionWe are seeking an experienced Pharmaceutical Procurement Specialist to oversee the management of pharmaceutical products across multiple facilities. The ideal candidate will possess strong negotiation skills, be able to manage vendor relationships, and ensure compliance with regulations and quality standards.About UsWe operate...

  • Pharmaceutical Quality Specialist

    2 weeks ago

    Nagpur, Maharashtra, India beBeeQuality Full time ₹ 1,00,00,000 - ₹ 1,25,00,000

    As a Quality Assurance Professional, you will play a pivotal role in ensuring the highest standards of product quality and safety.Our organization specializes in manufacturing Active Pharmaceutical Ingredients (APIs) and is committed to delivering high-quality solutions worldwide.We have a fully compliant facility with Good Manufacturing Practice (GMP)...

  • Pharmaceutical Accounting Specialist

    1 week ago

    Nagpur, Maharashtra, India beBeeAccountant Full time ₹ 8,00,000 - ₹ 12,00,000

    Pharmaceutical Accounting SpecialistWe are seeking an experienced accounting professional to manage full-spectrum accounting responsibilities in the pharmaceutical industry.Job Description:Maintain day-to-day accounts and general ledger entries.Prepare and file GST returns (GSTR-1, 2B, 3B, 9).Manage TDS deductions, payments, and return filing.Handle accounts...

  • Manufacturing Systems Expert

    1 week ago

    Nagpur, Maharashtra, India beBeeIndustrial Full time ₹ 6,00,000 - ₹ 8,00,000

    System Integration SpecialistJob Description:As a System Integration Specialist, you will play a pivotal role in driving innovative solutions in the manufacturing sector by leveraging your expertise in MES SCADA and IoT.We foster a collaborative work environment that encourages growth and creativity, providing our consultants with the autonomy to develop and...

  • Senior Pharmaceutical Market Access Specialist

    1 week ago

    Nagpur, Maharashtra, India beBeeMarketAccess Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    Market Access Expert Job SummaryWe are seeking a seasoned professional to spearhead market access initiatives, ensuring optimal product value realization in the pharmaceutical industry.Develop and execute strategic market access plans to secure favorable pricing, reimbursement, and patient access for pharmaceutical products.Analyze market trends, payer...

  • Manufacturing Technology Systems Expert

    1 week ago

    Nagpur, Maharashtra, India beBeeSCADATECHNICIAN Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

    About our client, a leading IT firm, we deliver industry-specific solutions to complex business challenges using domain expertise and deep technical capabilities.We partner with top-tier Indian multinational companies to address the needs of clients across various industries.Job Overview:Design, configure, and deploy Ignition SCADA and MES applications for...

  • Pharmaceutical Sales Territory Management Opportunity

    1 week ago

    Nagpur, Maharashtra, India beBeeTerritory Full time ₹ 6,00,000 - ₹ 12,00,000

    Pharmaceutical Sales Territory Manager Job DescriptionWe are seeking an experienced and dynamic individual to join our team as a Pharmaceutical Sales Territory Manager. In this role, you will be responsible for driving sales strategies and achieving business goals within your designated region.The ideal candidate will have excellent communication and...

  • Chief Manufacturing Executive

    2 weeks ago

    Nagpur, Maharashtra, India beBeeProduction Full time ₹ 15,00,000 - ₹ 20,00,000

    **Job Title:** Senior Production Manager**About the Role:** We are seeking an experienced Senior Production Manager to lead our production team. As a Senior Production Manager, you will be responsible for overseeing the entire production process, from planning and execution to quality control and assurance.**Key Responsibilities & Skills:Technical...