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.
RELEVANT EXPERIENCE: 10 -12 years in API projects Design, execution, commissioning & qualification.
Having strong knowledge of Utilities & HVAC.
Experience of execution/commissioning and Validation of formulation manufacturing equipment for oral solid dosage/Liquid forms
Strong projects and engineering background.
Having experience in independently managing site team, Contractors, Safety, Quality, Billing management.
Having strong command on Microsoft Office, Microsoft Projects & other project tracking tools.
Job Summary:**
PPL Pharma Inc. is seeking a highly experienced and technically proficient Senior Manager - Mechanical to lead and oversee all mechanical engineering aspects within our pharmaceutical manufacturing and R&D facilities. This role is crucial for ensuring the reliable operation, maintenance, and optimization of complex mechanical systems essential for drug production and research.
Job Responsibilities:**
Lead and manage a team of mechanical engineers and technicians, providing guidance, mentorship, and performance evaluations.
Oversee the design, procurement, installation, commissioning, and validation of new mechanical equipment and systems, including HVAC, cleanroom technology, process piping, utilities (WFI, purified water, compressed air, steam), and material handling systems.
Develop and implement preventative and predictive maintenance programs for all mechanical assets to minimize downtime and optimize operational efficiency.
Troubleshoot complex mechanical failures and lead root cause analysis investigations, implementing corrective and preventive actions.
Ensure all mechanical systems comply with relevant pharmaceutical industry regulations (e.g., cGMP, FDA, EMA), safety standards, and environmental guidelines.
Collaborate cross-functionally with R&D, Manufacturing, Quality Assurance, and Facilities teams to support project execution and operational excellence.
Manage budgets, schedules, and resources for mechanical engineering projects and departmental operations.
Identify and evaluate new technologies and best practices in mechanical engineering to improve facility performance and reduce operational costs.
Develop and maintain comprehensive documentation, including engineering drawings, specifications, maintenance procedures, and validation protocols.
Act as a subject matter expert for mechanical systems during internal and external audits.
Job Qualifications:**
Bachelor's degree in Mechanical Engineering with API Projects experiences.
Minimum of 10 -12 years of progressive experience in mechanical engineering.
Extensive knowledge of pharmaceutical manufacturing processes, cleanroom design principles, and cGMP regulations.
Proven expertise in HVAC systems, process utilities (WFI, clean steam, compressed air), piping design, and equipment validation.
Strong leadership and team management skills with a demonstrated ability to motivate, develop, and guide engineering professionals.
Excellent problem-solving, analytical, and decision-making abilities.
Proficiency in CAD software (e.g., AutoCAD, SolidWorks) and maintenance management systems (CMMS).
Exceptional written and verbal communication skills, with the ability to effectively present complex technical information to diverse audiences.
Strong project management skills with a track record of successfully delivering complex engineering projects on time and within budget.
Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
