Validation Lead/Associate III, Commissioning Qualification, Validation

Responsibilities

• Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
• Represent CQV in internal, client, and regulatory audits as needed.
• Develops procedures and supports the facility equipment qualification and validation program.
• Counsels and coordinates performance qualification execution for new products.
• Maintain and generate accurate and complete records, reports and documentation as required for summary preparation.
• Makes process improvements and modifications to the validation program as needed.
• Initiates and drives change controls (CCM).
• Reviews and approves Master Batch Records, Master Specification Sheets, Line Manufacturing Records and Bill of Materials.
• Authorizes and approves qualification and validation documents.
• Attends Equipment FAT, including international travel as required.
• Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).

Requirements (Education and Experience)

• Bachelor’s degree required, preferably in a science or technical area
• Minimum of 2 years related experience required, preferably 2 years supervisory experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Self-directed with high initiative and ownership
• Critical thinking, creative thinking, and problem solving skills

Physical / Safety Requirements

• Ability to meet Grade C and D gowning requirements.
• Duties will require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate equipment is required.
• Position requires standing for long hours, but may involve walking or sitting for periods of time.

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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