Engineering Manager bei Piramal Pharma Solutions
Piramal Pharma Solutions · Lexington, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Lexington
Business: Pharma Solutions
Department: Engineering
Location: Lexington
Job Overview
The Engineering Manager leads a team of multi-disciplinary manufacturing engineers, technicians, consultants and contractors to ensure the safe and reliable functioning of equipment and processes.
Key Responsibilities
- Manage equipment and utility related projects, including: on-site installation, startup, and commissioning activities for new equipment/systems
- Ownership of process equipment including continuous improvement and reliability activities, modernization/upgrades, event investigations/root cause analysis, cost reduction, and performance trending
- Primary/First Line responsibility for developing new processes and equipment to support business initiatives.
- Assist in the development of a robust operations and maintenance strategy
- Assist in the development of reliable and cost-effective spare parts program.
- Generate user requirements and engineering specifications for new equipment within area of responsibility
- Supports Operations including troubleshooting, emergency response, and normal coverage of a 24/7 manufacturing operation.
- Coordinate and conduct risk assessments
- Reduces downtime in accordance with applicable company and regulatory guidelines
- Responsible for the reliability of the production process (reliability of Validated Systems, Critical Utilities, and Production related systems is critical to the ability of the Lexington Facilities to successfully manufacture parenteral products).
- Improves key metrics (KPIs) around planning and scheduling (unplanned downtime, OEE, 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.
- Represents Technical Subject Matter Expert (SME) in equipment, facilities, process and utilities.
- Offers input for all functional budgeting, hiring, mentoring, employee evaluations and future direction of the Facilities/Engineering functions
- Provide support with customer requirements, communications and resolution of issues.
- Drive the manufacturing equipment/technology, automation, and facility strategies forward.
- Drive process improvement and lean manufacturing thru the corkscrew model of define, measure, analyze, improve and control to gain tangible improvement year over year.
- Lead process and product scale-up throughout the site, including troubleshooting complex engineering problems
- Ensure successful technological transfer of new products developed from R&D to commercial manufacturing and commercial site transfers.
- Manage / update site master plan to ensure alignment with strategy and updates to business and outside landscapes.
- Manage the Engineering Budget by monthly review and cost controls to ensure compliance
- Audit cGMP documentation of work performed.
- Ensure pFMEA is followed and that the process output for required spare parts inventories is maintained
- 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.
Education Requirements
- Bachelor’s degree in Mechanical Engineering or closely related scientific field
Experience
- 5+ years working within a pharmaceutical manufacturing or medical device environment
- 3-5 years of leadership experience, directly supervising a team of engineers, technicians, or contractors
Competencies
- Expertise in Engineering Project Management (including GAMP)
- Working knowledge of pharmaceutical processing equipment — Steam Sterilizers, Depyrogenation Ovens, Lyophilizers, Water Systems, VHP Generators, Lab Equipment, Precision Scales, HEPA Air Handlers, Isolators and Water Treatment Systems.
- Strong PC skills with standard office application (Word, Excel, PowerPoint) competency.
- Experience with MS Project or similar PM tools.
- Experience with AutoCAD or similar CAD tools.
- Experience with computerized systems for GMP and GMP QA Systems.
- Knowledge and understanding of cGMPs including FDA, JP and EU regulations.
- Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.
- Ability to lead and manage in approving function activities, following through to completion; must work with other functional groups’ priorities in order to drive Engineering projects to completion within the committed schedule.
- Must be able to interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies; must also interact with vendors and consultants on a routine basis.
About Company
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.
Company
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.
