Hybrid Role-minimum 50% onsite

Duration: 6 months(possibility of extension depending on performance of candidate)

Requirement

• Must be able to be on site at least 2-3 days/week.
• Required Bachelor's degree.
• Must haves - computer system validation w/a quality compliance mindset.

Top 3 skills/knowledge:

• Computer systems validation
• Proactive, self-motivated and needing minimum supervision
• Deviations and investigations
• MES systems preferred; delta v will work w/coding experience.

Position Summary

• Highly experienced computer systems validation professional with strong compliance mindset.
• Role will support the validation of computerized systems, including, but not limited to, process automation systems (DeltaV), manufacturing execution systems (MES), databases, Analytical Equipment, and IT infrastructure.

Detailed Position Responsibilities

• Oversee the qualification of process automation systems, Analytical and manufacturing instruments, manufacturing execution systems, databases, and IT infrastructure.
• Interface with MS&T, Validation, and end user groups as a Quality subject matter expert to provide technical validation guidance related to GxP compliance, design and requirements development, software testing, system administration, data management, and risk-management.
• Support the implementation and maintenance of Computer System changes, aligning with site compliance policies and procedures.
• Review and approve qualification protocols and test scripts, user acceptance testing, reports, change management, and authorization for use documentation.
• Ensure that all regulatory and cGMPs compliance items related to validation are satisfied.
• Review and approve exceptions associated with the qualification and participate in resulting investigations and correction / corrective action planning.
• Verify compliance with applicable Policies, Guidelines and Directives and ensures consistency with site procedures and/or specifications.

Desired Experience and Education:

• Knowledge of science generally attained through studies resulting in a Bachelor’s Degree in a scientific or engineering discipline.
• A minimum of 6 years’ experience in an environment governed by cGMPs, in a computer systems validation or quality assurance validation role overseeing electronic equipment and computerized systems validation
• Detailed knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
• Firm understanding of quality systems
• Proficiency in the use of computers and software applications including electronic validation documentation systems (such as ValGenesis and ALM)
• Demonstrated interpersonal, communication, and motivation skills.
• Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is required
• Knowledge of applicable business systems including: Veeva Vault is desirable
• Effective written and verbal communication skills Development Value
• Interface with many functional areas including Manufacturing Science and Technology, Digital Plant, Manufacturing, Validation.

Job Type: Contract

Salary: $70.00 - $78.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Overtime

Work setting:

• Hybrid remote

Ability to commute/relocate:

• Devens, MA 01434: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Computer systems validation: 6 years (Preferred)
• test scripts, user acceptance testing: 6 years (Preferred)
• pharma industry: 6 years (Preferred)
• quality systems: 6 years (Preferred)

Work Location: One location

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