Summary:

The Validation Engineer supports validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities, and computerized systems. These will encompass new facility/equipment/process, process and equipment changes, and periodic requalification/revalidation. The role reports directly into the Sr. Manager Validation and will be based at our San Digo Campus.

The Validation Engineer prepares validation plans, protocols, test scripts and reports throughout all stages of validation lifecycle. Furthermore, the role will be responsible for coordination and execution of validation activities and is expected to play a key role in developing and driving risk based validation approach during essential stages of product lifecycle including process design/control strategy development, technology transfer, equipment/utilities commissioning & qualification (C&Q), process performance qualification (PPQ), continued process verification (CPV), process control/risk management, and product decommissioning.

Your primary responsibilities:

• Perform qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification), cleaning validation, and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis.
• As needed coordinate and provide directions to contract personnel performing validation activities.
• Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
• Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
• Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization, and dry heat depyrogenation) development activities.
• Support periodic requalification and revalidation effort.
• Work independently and directly interface with personnel from multiple departments including Technical Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA.
• Support gap assessment/closure, corrective actions, and compliance remediation related to Validation.

Additional Responsibilities

• Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation.
• Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210).
• Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, ISO 14971, ASTM E2500, and applicable PDA Technical Reports).
• Experience with customer and regulatory inspection.
• Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
• Hands on validation experience in developing validation documentation and field execution.
• Project Management experience is a plus

More about us, benefits we provide you

• salary in line with the market as well as an annual bonus target, see pay scale below
• flexible working hours, 80% on site and 20% remote
• free parking
• Professional development opportunities (training, career development)
• Gym pass programm, Employees perks program
• 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)
• Health insurance: Medical, Dental, Vision
• Travel accident insurance, Life and AD and D Insurance
• Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages
• Adoption Assistance
• Employee assistance plan

Knowledge, Skills, and Abilities

• Familiarity and demonstrated knowledge of biologics manufacturing processes, including fermentation, purification, and bulk filling processes.
• Ability to work independently in a matrix team environment, influence team decisions, and exercise sound judgement in determining compliant and robust validation approach.
• Ability to multi-task with demonstrated track records in meeting deliverable timelines.
• Must demonstrate the ability to think critically and analytically with acumen for troubleshooting and problem solving.
• Good interpersonal skills, and accountable with excellent verbal and written communication skills.
• Ability to function effectively and independently in a fast-paced and dynamic environment.
• Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
• Ability to interpret engineering and facility drawings such as facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs.
• Expert Microsoft Word / PowerPoint and Intermediate Microsoft Excel skills are required.
• Understanding of basic statistics, acceptance sampling, and familiar with statistics software such as Minitab and JMP
• Strong team player aligned with Grifols Corporate Values.
• Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation, and sterilization validation experience (steam sterilization and dry heat depyrogenation) in GMP environment is required.
• Hands on experience with CIP/SIP cycle development and qualification is required.
• Automation and Part 11 validation experience is a plus.
• The engineer is expected to be proficient in at least 2 of 7 validation core expertise.

Validation Core Expertise:

• Facility Qualification
• Equipment Qualification
• Utilities Qualification
• Cleaning Validation
• Process Validation
• Sterilization Validation
• Computerized System Validation

Education & Experience

Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus.

Minimum 5+ years of relevant validation experience in regulated industry.

Equivalency

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

PayScale

The estimated pay scale for Validation Engineer role based in San Diego, California is $94,200 -$141,100 per year/per hour. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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