Validation Engineer
New Brunswick, New Jersey
- Temps plein
- Niveau : Premier
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Overview
Vous êtes une force énergique et collaborative à l’origine d’un processus de fabrication innovant à l’échelle mondiale, un processus qui permet d’offrir des médicaments de haute qualité au monde entier. Avec votre équipe, vous allez promouvoir de nouvelles approches, tester les limites et trouver la solution à chaque défi. Joignez-vous à un milieu de travail qui valorise vos contributions tout en soutenant votre croissance et votre réussite. Quand pouvez-vous commencer à travailler chez nous?
Profil de réussite
Quels sont les points forts d’un excellent Validation Engineer chez Sun Pharma? Jetez-y un coup d’œil et voyez si cela vous en dit.
- Collaboratif
- Industrieux
- Logique
- Résolveur de problèmes
- Responsable
- Énergique
Notre culture
Nous avons l’esprit d’équipe et sommes curieux. Des personnes autonomes qui se montrent à la hauteur des tâches à accomplir et sont fières de leur travail. Nous nous mettons au défi de trouver de nouvelles façons de faire la différence dans la vie des gens et dans nos carrières : de la formation à l’enrichissement en passant par les activités de cohésion d’équipe. C’est le mode de vie au sein de Sun Pharma. Et nous avons hâte que vous en fassiez partie.
Phani P. Directeur principal des activités de production“La fabrication pharmaceutique est l’équilibre entre offrir des produits pharmaceutiques accessibles et maintenir les normes de qualité les plus rigoureuses. Je suis fier de travailler dans un endroit où ma passion pour la production de produits de la plus haute qualité est partagée par tout le monde.”
Avantages sociaux
Nous sommes à vos côtés de bien des façons. Sun Pharma souhaite que vous profitiez des avantages, du soutien et des récompenses d’un travail bien fait.
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Développement de carrière
Obtenez du soutien pour votre développement de carrière et votre perfectionnement.
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Programmes d’avantages sociaux
Découvrez des avantages sociaux complets pour favoriser votre santé et votre bien-être, ainsi que ceux de votre famille.
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Congés
Profitez des options de congés payés et de congés autorisés.
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Rémunération
Obtenez une rémunération concurrentielle grâce à des programmes incitatifs qui récompensent notre succès commun.
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Conditions de travail
Travaillez en toute confiance dans un milieu de travail sécuritaire, propre et réglementé que nous promouvons.
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Environnement d’équipe
Collaborez dans un milieu de travail ancré dans nos valeurs et encourageant l’engagement entre les équipes.
Validation Engineer
New Brunswick, New JerseySun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.
We are seeking an experienced and detail‑oriented Validation Engineer to support equipment, utility, packaging, and computerized system validations in a regulated pharmaceutical manufacturing environment. This role is critical to ensuring compliance with cGMP standards, regulatory expectations, and internal quality systems while supporting production and engineering initiatives.
What You’ll Be Responsible For:
In this role, you will lead and execute end‑to‑end validation activities across manufacturing, packaging, utilities, and supporting systems.
Key Responsibilities Include:
- Prepare, execute, and document URS, IQ, OQ, and PQ protocols and validation summary reports.
- Perform validations for production and packaging equipment and utility systems including:
- HVAC
- Air compressors
- Boilers
- Purified Water Systems
- Area qualifications and warehouse temperature mapping
- Ensure all validation activities are completed on time and in compliance with cGMPs.
- Prepare and execute PLC validation protocols.
- Implement and maintain serialization and aggregation systems (e.g., Optel, Pharmaproof, Line Master), including cameras, scanners, and laser printers.
- Lead serialization packaging line IQ/OQ/PQ validations.
- Coordinate commissioning activities for new equipment and facility projects.
- Execute Periodic Performance Verification (PPV) activities.
- Develop calibration plans for newly installed equipment.
- Prepare, update, and conduct training for Setup, Operation, Cleaning, and Maintenance SOPs.
- Identify, investigate, and troubleshoot deviations across multiple concurrent projects.
- Design and document personnel, material, and waste flow throughout the facility.
- Support internal audits and regulatory inspections (FDA, DEA, and other agencies).
- Prepare, review, approve, and maintain Validation Project Plans, lifecycle documentation, and summary reports.
- Author and close investigations, change controls, and CAPAs in a timely manner.
- Develop SOPs for facilities and utilities.
- Monitor and follow up on maintenance work orders to ensure proper completion and documentation.
Education & Qualifications:
- Bachelor’s Degree in Engineering or related field.
- Strong technical and analytical skills to evaluate engineered systems, equipment performance, and quality systems.
- Solid understanding of cGMPs and Good Documentation Practices.
- Experience preparing and executing lifecycle documentation including:
- URS, FRS, VMP
- FAT, SAT, commissioning
- IQ/OQ/PQ
- SOPs, DS, CV, PV
- FMEA and Validation Master Plans
- Technical writing experience for change controls, investigations, SOPs, validation protocols, and final reports.
- Excellent verbal, written, and presentation communication skills.
- Self‑motivated with a hands‑on, proactive mindset.
- Proven ability to collaborate cross‑functionally and support team success.
- Strong project management and problem‑solving skills.
- English language proficiency at CEFR Intermediate B1+ level.
Experience:
- Minimum 4 years of experience in pharmaceutical manufacturing
- Oral Solid Dosage (OSD) experience strongly preferred
Work Schedule:
Monday-Friday, 9:00am-5:30pm
Work Environment:
This position operates across:
- Corporate office settings
- Manufacturing and production areas
- Warehouse environments
Exposure may include noise, dust, fumes, odors, gases, and industrial hazards typical of pharmaceutical manufacturing operations.
Physical Requirements:
- Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, push, and reach as needed.
- Lift, carry, or move up to 50 pounds.
- Navigate office, lab, and plant‑floor environments.
- Capable of wearing required personal protective equipment (PPE) including safety glasses, safety shoes, and respirators.
Why Join Us?
- Play a hands‑on role in maintaining regulatory compliance and product quality
- Work with advanced manufacturing, packaging, and serialization technologies
- Collaborate with cross‑functional engineering, quality, and operations teams
- Contribute directly to continuous improvement and operational excellence
Ready to make a difference? Apply today!
The presently-anticipated base compensation pay range for this position is $84,500 to $94,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
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 (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.
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