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JOB SUMMARY

Reporting to the Senior Manager process Validation, the Process Validation Engineer III/IV is accountable for guiding teams and performing validation activities such as Performance Qualification (PQ), Process Validation (PV) and Revalidation (RV) in support of cGMP pharmaceutical/medical device contract manufacturing across multiple PCI facilities. These Process Validation activities include working with clients to define process control parameters and design protocols to test and verify process robustness. The role requires audit and inspection management support. In collaboration with validation management, assist internal project teams and external validation firms on Validation/qualification initiatives and to ensure project schedules are met. Complies with PCI Health and Safety mandates and OSHA requirements. The PV Engineer III/IV will contributes and promotes a positive and equitable working environment emphasizing the PCI Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. This position will support the process validation management in helping to train and mentor less experienced process validation Engineers. The role may also require supporting internal/external audits and other lifecycle activities to support the process validation program.

EXPERIENCE

• Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
• Proficient in the development and execution of PPQs. Review commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
• Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
• Validation experience with the following is highly preferred: Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics.
• Engagement and knowhow with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.

PROFESSIONAL SKILLS

• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP fill finish facilities. Understanding of the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
• Possess strong knowledge of Process Performance Qualification /Validation practices, including applicable regulations.
• Excellent technical writing, verbal communication and presentation skills.
• Proven capabilities to successfully bring cross-functional teams together to achieve goals through strong positive influence and leadership direction
• Proficiency in Microsoft Office including Word, Excel, Power Point, Project

EDUCATION

• Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required with a minimum of 7 – 10 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, MTS, Process Development or Engineering.

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Ability to lift 50 pounds
• Must be able to stand for long periods of time each day
• Travel and work at all LSNE site locations/facilities
• Ability to multitask with competing demands and at times shifting priorities.
• Able to don ISO cleanroom gowning and PPE, as required by site procedures.

JOB DUTIES

• Develop and support the detailed project plans and timelines for the execution of process validation activities.
• Prepare validation & change control documentation, including protocols, summary reports, etc.
• Author Process qualification/ verification validation plans; this includes the development of client specific process requirements and specifications drafts to execute process performance qualifications, process simulation media fill protocols. Also compile trace matrices, perform data analysis, draft validation protocol discrepancy reports and draft process validation summary reports
• Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes
• Participate in client and Regulatory Audits. Work on CAPA and QS with minimal oversight to achieve timely results
• Assist with determining impact of change control on qualified process and aseptic operations.
• Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance, and project management to achieve all project deliverables.
• Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation. Perform all functions associated with process validation support.
• Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
• Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.
• Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping the manager updated regularly.
• Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping teammates and manager informed and providing guidance to other engineers as needed.
• Write process validation and process simulation media fill protocols and technical study approaches.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

• None
  TRAVEL – Approximately 15%
  

  LI-LL1

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status