Pkg. Validation Engineer

Job Title:                                   Pkg. Validation Engineer

FLSA Classification:                Professional, Exempt 

Work Location:                         Fall River, MA

Work Hours:                             General Shift: 8:30AM – 5:00PM (may vary based on business needs)

Reports To:                               Department Head Packaging

Salary Range:                          $62,400 – $75,400

Scope:                        

Invagen Pharmaceuticals is searching for experienced candidates for the position of Validation Engineer.

The Validation Engineer is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role the Validation Engineer adheres to the company’s document and SOP’s procedures while ensuring their accuracy, quality, and integrity.  This position reports to the Manufacturing/Packaging and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.  

The job duties for this position include but are not limited to the following:

• 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 the environment.
• 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 automization of pharmaceutical equipment.
• Performs other duties as assigned.

Education and Experience

• Bachelor’s degree in engineering or related field from an accredited institution.
• Master’s degrees in advanced and related discipline preferred.
• 2-year experience in installing, testing, maintaining and repairing pharmaceutical or Biomedical machinery.

Technical Knowledge and Skills

• Excellent understanding of Equipment and Facilities Qualification and Validation processes and protocols
• Must have knowledge in troubleshooting and fault finding in PCB, on-site repairs and maintenance of any process or utility equipment.
• Must have experience programming, modifying, troubleshooting and testing PLCs for compression, encapsulation, granulation, packaging and coating process machines.
• Must be proficient with: PLC programming, troubleshooting.
• Must be proficient with E-designer, Cadence Virtuoso, HSPICE, ModelSim, Eclipse, PSpice, Matlab, AutoCAD, Windows OS.
• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suite.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Experience in Inhalation products (MDI) is a plus.

Professional and Behavioral Competencies

• Ability to read, write and communicate effectively.
• Ability to work effectively both independently and as part of a team.
• High energy level, comfortable performing multifaceted projects in conjunction with day-to-day activities.
• Strong technical & troubleshooting abilities in a variety of manufacturing disciplines including demonstrated expertise in a production environment
• Ability to understand and analyze complex data sets.
• Knowledge of good manufacturing practices and good documentation practices preferred.

• 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.

Work Schedule and Other Position Information: 

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.

GLOBAL COMPANY

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies.  Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare.  The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future.  Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.