DIRECTOR ENGINEERING
Apply NowCompany: Piramal Group
Location: Sellersville, PA 18960
Description:
Job Description
Job Overview
The Director of Engineering directs and coordinates the activities of the plant Engineering staff to design plant facilities, manage construction activities, maintain environmental compliance, identify and take action in areas of energy conservation, maintain best practices to ensure cGMP compliance, and comply with various regulatory requirements pertaining to engineering activity. The position provides technical leadership and administrative control to ensure efficient operations and management of plant equipment and engineering functions, maximizes capacity and optimizes utilization of resources, and develops systems and processes for high performance delivery.
Key Stakeholders: Internal
Site Functions, Corporate Functions (SCM, CQA, CRA, Projects, Finance), Engineering groups of other PPL sites
Key Stakeholders: External
Govt. Departments, Regulatory Agencies, Customers
Reporting Structure
Reports to Site Head
Key Roles & Responsibilities
Qualifications
Qualifications
Desired Qualifications
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.
Job Overview
The Director of Engineering directs and coordinates the activities of the plant Engineering staff to design plant facilities, manage construction activities, maintain environmental compliance, identify and take action in areas of energy conservation, maintain best practices to ensure cGMP compliance, and comply with various regulatory requirements pertaining to engineering activity. The position provides technical leadership and administrative control to ensure efficient operations and management of plant equipment and engineering functions, maximizes capacity and optimizes utilization of resources, and develops systems and processes for high performance delivery.
Key Stakeholders: Internal
Site Functions, Corporate Functions (SCM, CQA, CRA, Projects, Finance), Engineering groups of other PPL sites
Key Stakeholders: External
Govt. Departments, Regulatory Agencies, Customers
Reporting Structure
Reports to Site Head
Key Roles & Responsibilities
- To ensure efficient operation, maintenance and upkeep of Plant Equipment and Utilities.
- To 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, periodically reviewing departmental SOP's.
- Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
- Ensure execution of Preventive & breakdown maintenance activity as per SOP.
- Maximizing plant uptime by keeping track of OEE & breakdown reports.
- Meet internal customer expectations on costs and quality deliverables
- Control engineering costs and ensure they remain within reasonable variance of sanctioned budget.
- Ensure uninterrupted utility services to plant to achieve targeted production.
- Identify area of energy conservation, plan propose and drive Energy Conservation projects and initiatives.
- Approve purchase requisitions in SAP system.
- Approve Challans and Bills of engineering items/services.
- Ensure execution and timely completion of various projects.
- Monitor & control the Engineering CAPEX and OPEX budget.
- To ensure that Engineering team delivers as per the KPIs.
- Ideation and implementation of cost optimization/de-bottlenecking projects
- Participate in various operational projects like ERP, refurbishment / modification of areas
- Provides direction and guidance to ensure quality, safety, and regulatory compliance with applicable federal, state, and local environmental regulations, company policies and procedures, and GMP
- Responsible to maintain knowledge of changes or updates to requirements and share those changes with Engineering and Facilities department
- To perform functions of the MR (Management Representative) of EHS management system.
- Responsible for effective implementation of EHS Management system in accordance with the requirements of ISO 14001:2015 and ISO 45001:2018.
- Directs the training and development of facilities and engineering employees to ensure task completion. participates in team development activities and ensures staff operates successfully in a team environment
- Identify training needs where necessary to ensure department success
- Coach employees and manage department challenges with the help of HR.
- Conduct Departmental Meetings - A two way communication process for reviewing various points for improvement in the dept.
Qualifications
Qualifications
- Bachelors degree in Mechanical Engineering or related technical/engineering field with 10 years of related experience or
- Masters degree in Engineering or related field with 5 years of related experience or
- Ph.D. with 3 years of related experience
- 6 years of supervisory experience preferred
- Experience independently handling engineering and maintenance functions of manufacturing unit involved in drug products (sterile and non-sterile dosage forms)
- Experience with regulatory and customer audits
- Individuals with equivalent combination of education, training, and related experience will be considered.
Desired Qualifications
- 6 years supervisory experience
- Knowledge of or working in the following areas; Project Management, Special Projects, Validation, production processes such as Granulation, Encapsulation, Packaging
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.