Shire Jobs

Job Title

Validation Engineer

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

Central Islip or Hauppauge, NY

Employment Type

Full Time

Salary Range

(Base/salary)

$ 75k - $85k

Benefits

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.

Work Hours/ Shift/ Remote

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.

Responsibilities/ Accountabilities

• 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.

Education Qualifications

• 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.

Experience

• 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.

Skills/ Competencies

• Must have excellent communication skills.
• Maintain a positive, professional attitude towards work and willingness to cooperate with co-workers and supervisors.

Physical Requirements

• 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.