What are the responsibilities and job description for the Facilities Manager position at Piramal Pharma Ltd?
Job Description
The Facilities Manager oversees a team of technicians, working to ensure the preventive and corrective maintenance of plant mechanical systems in a cGMP manufacturing environment. This is a safety- sensitive position.
Key Responsibilities
QUALIFICATIONS
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.
The Facilities Manager oversees a team of technicians, working to ensure the preventive and corrective maintenance of plant mechanical systems in a cGMP manufacturing environment. This is a safety- sensitive position.
Key Responsibilities
- Manage a team of multi-disciplinary maintenance and calibration technicians, consultants, contractors, or others as assigned in meeting the team, site and corporate objectives.
- Provide performance management including career development, coaching & mentoring, and adhering to the PPS timelines and milestones for performance reviews and goal setting for all direct reports.
- Coordinate the maintenance of all mechanical systems.
- Coordinate the calibration and qualification of all instrumentation and related equipment.
- Ensure schedule adherence and compliance of PM and CAL events
- Ensure that equipment monitoring and proper documentation is performed.
- Audit cGMP documentation of work performed.
- Participates in cross functional teams to meet deadlines and achieve project objectives
- Work in a collaborative team environment and interact with other business units.
- Maintain spare parts inventories
- Interact and provide direction to direct reports and service providers/vendors relevant to area of responsibility
- Support any function of the other departments as necessary (e.g. Engineering and Validations)
- Ensure that work is performed within established safety guidelines.
- Ensure that clean and orderly work areas are maintained.
- Ability to write, revise and review relevant protocols and procedures.
- Supports Operations including troubleshooting, emergency response, and normal coverage of a 24/7 manufacturing operation.
- Reduces downtime in accordance with applicable company and regulatory guidelines.
- Develops, tracks and, improves key metrics (KPIs) around planning and scheduling (unplanned downtime, OEE, etc).
- Complete investigations and action items for equipment or calibration failure events
- Supports FEQ team and leadership on site initiatives, projects, day-to-day support, data gathering, etc.
- Develops/reviews and approves design documents, drawings, project plans, change controls, SOPs, PMs, cals, work orders, validation protocols and final reports and ensures compliance with cGMPs and current regulatory requirements. Resolves all deviations/discrepancies encountered during project execution.
- Reviews change requests for impact to equipment or process and supports QA compliance activities such as Product Quality Review.
- Other duties as assigned.
QUALIFICATIONS
- B.A. or B.S. in a technical field or equivalent work experience
- 5 to 10 years of Maintenance/Instrumentation Supervision experience in a regulated industry, preferable in a pharmaceutical environment is required.
- Ability to interpret engineering drawings
- Use applicable software such as MS Office, MS Project and Work Order software
- Ability to troubleshoot equipment problems using a variety of tools and diagnostic instrumentation.
- Working knowledge of Pharmaceutical processing equipment — Steam Sterilizers, Lyophilizers, Water Systems, Bin Blinders, Lab Equipment, Precision Scales, HEPA Air Handlers, Tablet Presses, Packaging systems and Water Treatment Systems.
- Familiarity with automated control systems and PLC interfaces
- Lift up to 40 lbs. and occasionally move drums weighing up to 300 lbs.
- Able to work safely with heavy equipment.
- Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
- Ability to climb ladders, bend, stoop, and kneel.
- Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
- Not allergic to chemicals or bio-substances found in laboratory or production facilities.
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.
