Talent.com
Senior Validation Engineer (Contract)

Senior Validation Engineer (Contract)

Veranova L PDevens, MA, US
19 hours ago
Job type
  • Temporary
Job description

Job Description

Job Description

Discover Veranova

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focuses on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation.

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients.

Role Overview :

This role is responsible for managing and executing validation activities for new and existing process equipment and support systems used in the development and manufacture of pharmaceutical APIs at Veranova’s Devens and North Andover facilities. The position will provide temporary support for commissioning, qualification, and validation (CQV) efforts associated with strategic site projects, including new equipment and system installations. The successful candidate will ensure compliance with regulatory standards and internal quality requirements while supporting project timelines and operational readiness.

Please note : This is a temporary contract role.

Core Responsibilities :

  • Validation

Generate, execute, review, finalize, and approve validation / qualification protocols and reports

  • Manage and update project validation plans for specific projects
  • Assist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines.
  • Utilize computerized asset management system for managing validation / qualification schedules
  • Generate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports
  • Attend vendor FAT (Factory Acceptance Tests) if required.
  • Work with other departments to develop equipment specifications and process system designs
  • Project

    • Ability to meet project deadlines and goals.

  • Investigation and resolution of equipment and system problems
  • Assist in the calibration, adjustment, and modification of plant and lab process instrumentation
  • Ability to manage several projects simultaneously

    • General

    Perform duties according to GMP standards and internal standard operating procedures

  • Work safely, injury free, and actively participate in improving department and site safety performance
  • Provide technical support to the Maintenance, Production, Lab and Calibration departments
  • Aid in continuously improving the efficiency and effectiveness of the system

    • Qualifications : Required

  • Bachelor’s degree required; B.S. in engineering preferred.
  • 6+ years of experience in an Engineering or a closely related role in a manufacturing or R&D environment.
  • Experience in a GMP environment required. Experience in the pharmaceutical / API / chemical manufacturing industry preferred.
  • 3+ years of experience in a Validation Engineering role generating and executing Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols
  • At least 1 year of experience as a Validation Contractor working in a cGMP industry.
  • Understanding of best industry practices surrounding Validation.
  • Excellent writing and communication skills
  • Able to physically enter tight spaces, climb ladders and work from heights
  • Able to wear various types of respirators, protective clothing and hearing protection

    • Preferred

  • Understanding of electrical systems
  • Understanding of control systems

    • Compensation :

    This is a contract role. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors.

    Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.

    Additional Information :

    Applicants for this role must be authorized to work in the United States without further employer sponsorship.

    Agency and Search Firm Representatives : Veranova does not accept unsolicited resumes from agencies and / or search firms for this job posting.

    All your information will be kept confidential according to EEO guidelines.

    Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and / or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

    All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

    #LI-Onsite

    Create a job alert for this search

    Validation Engineer • Devens, MA, US