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Process Validation Engineer II/III

  • Permanent
  • Anywhere

Website TalentBurst, Inc.

TalentBurst, Inc.

Company : TalentBurst, Inc.

Country: United States

Location : Greenville, North Carolina

Post: Fri, 09 Sep 2022 15:26:36 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

TITLE: (Sr.) Process Validation Engineer

LOCATION: Greenville, NC

INDUSTRY: Pharmaceuticals

MODEL: Permanent, Direct Hire

Key Responsibility Areas

Oversee Site Master Validation Program: Provide input and administration of the site master validation program as well as assist in maintaining the site validation master plan; support validation policy; maintain validation life cycle approach for site

Pharmaceutical Validation: Author, review, execute process validation protocols and validation summary reports; perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification

Safety: Adhere to all workplace safety laws, regulations, standards, and practices and actively advance a culture of safety within his or her team and organization

Specific Responsibilities

Responsibilities include, but are not limited to:

Equipment/Facilities/Utilities Qualification

Author/Review equipment qualification protocols and summary reports

Author/Review executed equipment qualification protocols and summary reports

Assist with execution of equipment qualification protocols

Part 11/Computer Systems Validation

Collaborate with Automation/IT and Commercial Operations to determine and develop URS, SDS, and a Validation Project Plan

Author/Review CSV qualification protocols and summary reports

Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and determine validation impact and make final validation disposition decision.

Author/Review executed CSV qualification protocols and summary reports

Periodic Review and Revalidation

Manage Scheduling, Tracking, and Deviations related to Periodic Review and Revalidation activities and workload

Author/Review/Perform Periodic Reviews / Revalidations (protocols and summaries) for scheduled equipment

Assist with execution of equipment revalidations

Follow procedures, schedules, and ensure compliance is maintained

Site Master Validation Program

Follow the site master validation program

Follow and enforces the validation life cycle approach for site

Provides support during client and regulatory audits

Ensure validation documentation is archived appropriately according to GMP documentation retention guidelines and readily available for client and regulatory audits

Create and maintain a climate of quality and safety within the team and other departments, by identifying and monitoring quality and safety standards

Key Competencies/Requirements

Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others

Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems

Creativity: Explore and advances opportunities to develop Client solutions and approaches to the improvement of processes and services

Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates

Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas

Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people

Attention to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled

Teamwork: Work well with others while providing support and assistance to team members to help accomplish objectives

Time Management: Establish a systematic course of action for self or others to ensure accomplishment of a specific objective; set priorities, goals, and timetables to achieve maximum productivity

Qualifications

Bachelor’s degree in a Technical or Life Sciences discipline with at least 2 years of experience in the pharmaceutical industry

Associate degree in a Technical or Life Sciences discipline with at least 4 years of experience in the pharmaceutical industry

2 years recent experience in one or more of the following areas: process validation, equipment validation, CFR 210 Part 11 software validation or cleaning validation with at least one-year experience preparing and implementing process validation protocols and authoring validation summary reports

Physical Requirements

Some exposure to hazardous chemicals and other active chemical ingredients

Position requires the capacity to handle and manipulate objects using hands and arms

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