Job description

Summary

We are looking for someone who will support validation activities related to facility, manufacturing process, cleaning process, equipment, critical utilities, and computerized systems.

Roles & Responsibilities

· These will encompass new facility/equipment/process, process and equipment changes, and periodic requalification/revalidation.

· The incumbent prepares validation plans, protocols, test scripts and reports throughout all stages of validation lifecycle.

· Furthermore, the incumbent will be responsible for coordination and execution of validation activities and be 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.

· 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.

· As needed represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections.

· As assigned mentor and manage fulltime validation engineers/specialist and contractors.

· Validation Core Expertise:

· Facility Qualification

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

· Expert Microsoft Word / PowerPoint & Intermediate Microsoft Excel skills are required.

· Be able to lift 20 lbs.

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

· Minimum 7+ years of relevant validation experience in regulated industry.

· Bachelor's Degree

Minimum Qualifications

· 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

· Familiarity & demonstrated knowledge of biologics manufacturing processes, including fermentation, purification & bulk filling processes.

· Ability to work independently in a matrix team environment, influence team decisions, exercise sound judgement in determining compliant & robust validation approach.

· Ability to multi-task with demonstrated track records in meeting deliverable timelines.

· Must demonstrate the ability to think critically & analytically with acumen for trouble-shooting & problem solving.

· Good interpersonal skills, accountable with excellent verbal & written communication skills.

· Ability to function effectively & independently in a fast-paced & dynamic environment.

· Self-motivated & willing to tackle assignments & development opportunities outside of job scope.

· Ability to interpret engineering & facility drawings such as facility layouts, blueprints, material/process flow diagrams & equipment P&IDs.

· Understanding of basic statistics, acceptance sampling & familiar with statistics software such as Minitab & JMP

· Strong team player aligned with Grifols Corporate Values.

· Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation & sterilization validation (steam sterilization & dry heat depyrogenation) in GMP environment is required.

· Hands on experience with CIP/SIP cycle development & qualification is required.

· Hands-on engineer.

· The engineer is expected to be proficient in at least 4 of 7 validation core expertise.

Work Authorization

• Green Card
• US Citizen
• Employer Authorization Doc. (EADs)
• TN (Canadian Visa)
• Curricular Practical Training. (CPT)
• Occupational Practical Training (OPT)

Job Type: Contract

Salary: $90.85 - $92.85 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Emeryville, CA 94608: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• GMP manufacturing

Experience:

• Validation engineer: 1 year (Preferred)

Work Location: One location

Speak with the employer
+91 7001529506

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