Process Validation Engineer/Scientist, Manufacturing Science & Technology Group (MSTG) (Second Shift)
The world’s largest pharmaceuticals market is also the biggest market for Sun Pharma. We have been present in the US since 1996, working with the country’s healthcare system with a focus on generics, branded generics and over-the-counter (OTC) products. We are valued suppliers to the largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers. Being a vertically integrated company with a global presence, we have the flexibility to develop and manufacture products in the US as well as at other locations across the world. Our US headquarters is located in Cranbury, New Jersey and we have manufacturing, distribution and customer service teams at multiple locations across the country.
Very important note: The individual hired for this position will work on first shift (weekdays 7:30 a.m. - 4:00 p.m.) for the initial two to three week training period and then transition to working second shift hours (weekdays 2:30 p.m. - 11:00 p.m.) thereafter.
J ob Summary:
Application and proper implementation of technical, quality, and scientific principals necessary to meet industry and customer requirements. This individual is expected to work in a team environment or independently to meet defined objectives based on established timelines and deliver project work in a manner that is consistent with the company’s values.
Essential Job Functions:
Responsibility for preparation of pre-validation and process validation documentation such as CCRs, MBRs, protocols, and reports.
Performs optimization, process studies, characterization, and process validation as well as process troubleshooting, process optimizations and assisting in investigations.
Assist production shifts to ensure smooth transfer of new products or process enhancements of existing products.
Oversee manufacturing of process pre-validation and validation batches.
Oversee manufacturing of exhibit test batches, in case of alternate sources.
Preparation of Master Batch Records and maintenance in current status.
Support R&D in process development, process optimization, and filing of new ANDAs and NDAs.
Performing process evaluation using statistical tools and perform trend analysis.
Preparation of SOPs related to Manufacturing Science & Technology Group (MSTG) and maintenance in current status.
Troubleshooting and preparation of Corrective and Preventative Action Plans (CAPAs).
Support or champion compliance investigations, commitments (CAPA), and change controls.
Participate on cross-functional team that address specific problems, facilitate discussion and research, enabling procedures to become more efficient, and to build and enhance interdepartmental relationships.
Provide support during audits and with audit observation closure.
Additional responsibilities as assigned.
Bachelor of Science and/or Master of Science in pharmacy or relevant science/engineering discipline
Minimum one to two years of experience in solid oral manufacturing (tablet or capsule), validation and/or formulation development/technical services
Experience in transdermal products and/or fluid bed drying strongly preferred
Technical understanding of pharmaceutical unit operations
Self motivated, positive attitude, organized and ability to adapt to changing priorities
Excellent documentation skills
Computer skills: Microsoft Word, Excel, PowerPoint, Minitab Software
Ability to work well in a team setting and work on multiple projects simultaneously
Ability to work an alternate shift when required per business needs
Ability to work overtime when required per business needs.
Work Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office or manufacturing environment. The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend.
Must be capable of bending and lifting, moving and/or carrying up to approximately 50 pounds.
Must have the ability to navigate office and plant floor working environments, stands, ambulates, and reaches.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.