Cipla USA · 1 week ago
Validation Engineer - Manufacturing
Fall River, MA
Full-time
Onsite
Mid, Senior Level
4+ years expCipla USA is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. They are seeking a Manufacturing Validation Engineer responsible for the creation and revision of GMP documents, ensuring compliance and operational success through user-focused documentation.
Pharmaceuticals
Responsibilities
Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency
Creates training materials for subject matter input
Track and manage periodic review
Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance
Autonomously leads and manages projects to implement continuous improvement opportunities
Lead and/or support root cause investigations related to performance trends and formal deviations
Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact
Reviews document for accuracy and completeness
Defends the validation programs and strategies to customers and regulatory auditors
Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols
Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment
Performs other duties as assigned
Knowledge of qualification and validation documents
Preparation of qualification and validation documents of equipment and computer system
Preparation and qualification of e-batch record & e-Log Book
Knowledge of cleaning validation and process validation
Knowledge in project handle with new equipment
Knowledge of URS, FDS, DQ, HDS, SDS, FS, validation plan, FAT, SAT, IQ, OQ,PQ, validation certificate, PIR,RTM, electronic signature, electronic reports
Knowledge of 21 CFR and implementation. Knowledge of automation of pharmaceutical equipment
Qualification
Required
Associate's degree with 4-6 years knowledge and experience of GMP documentation required
Minimum four (4) years documentation experience and six (6) years related pharmaceutical or biotech industry experience
Excellent communication skills, drive, and sense of urgency
Excellent computer skills, specifically Microsoft Office Suite
Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives
Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment
Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team-based environment
Knowledge of pharmaceutical manufacturing and related documents
Knowledge and experience writing, revising and creating cGMP records and SOPs
Knowledge of GDP
Creation and maintenance of batch record and cGMP documentation templates
Hands-on experience facilitating problem solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems
Ability to work effectively both independently and as part of a team
Capable of handling and participating in compliance and regulatory audits at the local and federal levels
Proficiently speak English as a first or second language
Ability to understand and analyze complex data sets
Ability to read, write and communicate effectively
Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously
Position requires flexibility to quickly adapt to changing work environment and schedules
Excellent organizational skills with the ability to focus on details
Good basic math knowledge and excellent attention to details
Preferred
Bachelor's degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or related discipline from an accredited college/university
Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university
Preference will be given to candidates with experience in generic pharmaceutical manufacturing
Experience using SAP business system and applications is a plus
Experience in Inhalation products (MDI) is a plus
Knowledge and handling of deviation, CAPA, change control, FMECA and training
Knowledge and handling of SAP system, master control and Track wise system
Knowledge of audits and compliance
Knowledge of statistical packages is a plus
Knowledge of good manufacturing practices and good documentation practices preferred
Company
Cipla USA
Cipla USA, the wholly owned subsidiary of Cipla (established in 1935), has been enabling patient access to affordable and high-quality medicines in the US for over 30 years.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Arunesh Verma
President & CEO, Cipla North America
Marc Falkin
Executive Vice President / Chief Commercial Officer
Company data provided by crunchbase