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Job Title
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Validation Engineer
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Organization Name
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InvaGen Pharmaceuticals, Inc.
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Location
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Central Islip or Hauppauge, NY
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Employment Type
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Full Time
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Salary Range
(Base/salary)
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$ 75k - $85k
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Benefits
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In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.
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Work Hours/ Shift/ Remote
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Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
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Responsibilities/ Accountabilities
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- Assists with developing qualification protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment/systems qualifications and validation protocols.
- Supports vendor's qualification functions.
- Assists with developing written procedures for operation and preventive maintenance of equipment and systems.
- Assists with developing validation/qualification deliverables such as Requirements Specifications, Risk Assessments, Traceability Matrices, and validation Summary Reports.
- Supports internal groups in the procurement, operation, calibration, and preventive maintenance of equipment/systems to meet business needs in accordance with required schedules or dates.
- Completes all calibration, qualification, and validation documentation with accuracy, completeness, and compliance.
- Regularly reviews, prioritizes, and promptly responds to MFG and QA equipment qualification/system validation and support requests.
- Maintains a positive relationship with all team members while promoting a positive team environment.
- Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
- Perform entire duties as communicated time to time by department management/designee.
- Enforce and follow safety regulations and ensure the working area is clean.
- Adhere to CIPLA’s Safety, Health, and Environmental policies.
- Must be able to work under general supervision and able to work independently and in a team environment.
- Must be able to exercise appropriate professional judgment on matters of significance.
- Other duties assigned as required by Maintenance management.
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Education Qualifications
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- Bachelor’s degree, advanced vocational training or education in pharmaceutical engineering, industrial engineering, or related field of study from an accredited college/university is preferred.
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Experience
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- 2+ years of experience in validation, and quality assurance in pharmaceutical field
- 1+ years of direct experience in the Equipment validation/qualification, utility, and facility qualifications
- Hands on experience working with GAMP 5 systems and 21 CFR Part 11 compliance.
- Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU/MHRA data integrity guidance.
- Ability to work as part of a cross-functional team in a dynamic, fast-paced environment.
Ability to effectively communicate with team members, contractors, and vendors.
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Skills/ Competencies
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- Must have excellent communication skills.
- Maintain a positive, professional attitude towards work and willingness to cooperate with co-workers and supervisors.
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Physical Requirements
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- This position requires the ability to do heavy lifting / bending frequently.
- Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
- Requires the ability to work indoors and outdoors.
- Must be physically capable of climbing ladders, working with hardware, working in a lying position, working with arms extended overhead for extended periods of time.
- Ability to wear appropriate PPE is required.
- Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.
- Must communicate clearly and concisely across levels, both orally and in written.
- Strong command of written and verbal English is required.
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About Cipla
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. Driven by the purpose ‘Caring for Life’, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.
InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary 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. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States.
Equal Opportunity Employer
Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.
About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
