Senior Validation Associate

Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals.

At our San Diego site, we are currently looking for aSenior Validation Associate to be a part of our growing team.

Wacker Bitotech is seeking a highly organized and motivated team member to join our Validation team. This individual will provide validation oversight for qualification activities associated with equipment, facilities, and other support systems to ensure compliance with applicable current Good Manufacturing Practice (GMP) regulations, corporate policies, and internal Standard Operating Procedures (SOP). The position will be responsible for performing complex validation and qualification activities for equipment, facility/utilities and processes used in cGMP Manufacturing and Quality Control.

The position is responsible for scheduling activities with equipment owners and ensuring routine activities are completed on time, performing validation documentation preparation and review for manufacturing process, equipment, and utilities in accordance with relevant guidance documents and current industry best practices, executes validation protocols, writes validation and qualification summary reports.

Essential Functions:

1. Assist and lead validation activities supporting manufacturing at WBU site
2. Generate, review, approve a variety of qualification lifecycle documents such as validation plans, URS, DACS, IOQs, PQs, RTMs and summary reports for equipment, facilities, utilities and cleaning to ensure compliance with established procedures and aligned with regulatory requirements and industry best practices.
3. Execute and/or manage protocol execution and perform data review to determine adherence to specifications.
4. Generate protocol deviations including conducting investigation to determine the root cause and implementation of corrective action(s).
5. Support the quality risk management program including generating risk assessment.
6. Provide oversight of validation contract resources and/or vendors including review of vendor protocols/packages and creation and/or approval of in-house protocols and reports to deliver a complete package of qualification documentation.
7. Maintain the qualified state of WBU equipment/systems through the execution of re-qualifications
8. Perform document change requests to validation procedures, support change controls and initiate quality records such as quality deviations, CAPA as needed.
9. Work closely with all departments to ensure the operation of a validated environment according to GMP and other regulatory requirements.
10. Expected to contribute in regulatory filings and inspections.

Required Education and Experience

• Bachelor's degree in science with 5+ years OR MS/PhD with 4+ years of GMP/Relevant Industry Experience. (Chemistry, biochemistry, Engineering, or related discipline preferred)
• Must have 5+ years of experience in pharmaceutical (FDA regulated industry) validation
• Experience of wide range of validations including equipment, cleaning and utility and facilities validation plans.
• Must have strong hands-on, end-to-end validation experience and application of project controls / management - including familiarity with all project lifecycle phases from requirements gathering through delivery, issues / risk management, change management, release management and retirement management

Critcal Knowledge, Skills and Abilities

• GMP, GAMP, Annex 11 & 15,
• Experience in HVAC design principles
• Good understanding of USP Purified Water and WFI System qualifications
• Statistical analysis
• Excellent analytical interpretation skills
• Risk-based application of validation principles
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution
• Implementing change initiatives and leading change.
• Strong problem solving and decision-making skills
• Good organizational skills and attention to detail.
• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels.
• Ability to handle multiple assignments and changing priorities.
• Positive, proactive approach to drive assignments/tasks to completion.
• Proficiency with Microsoft Word, Excel, PowerPoint
• Ability or capable of lifting up to fifty (50) lbs.

Preferred Qualifications:

• Direct hands- on experience qualifying HVAC systems and clean room qualifications including technical protocol writing and working knowledge of relevant regulatory expectations.
• Direct hands- on experience USP Purified Water and WFI System including technical protocol writing and working knowledge of relevant regulatory expectations.

We are looking forward to your online application!

The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.

In accordance with the Internal Placement Policy, you must be in your current role for at least one year, and must inform your current supervisor prior to applying for a new position. If you have any questions or concerns, please contact your local HR department.

A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.