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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.

General Description:

We are seeking experienced consultants who can provide support as Commissioning, Qualification and Validation (CQV) Engineer for a variety of projects. Each qualified candidate will be responsible for coordinating commissioning, qualification and validation activities across all operational areas and ensuring activities are conducted in a timely manner in accordance with cGMP and appropriate regulatory expectations.

KEY RESPONSIBILITIES AND ACTIVITIES

• Develop Master Validation Plans for communicating commissioning, qualification and validation approach and requirements.
• Develop validation requirements for projects related to new equipment, processes, and facilities.
• Development, revision, coordination, and execution of protocols for qualification of equipment, systems and validation of processes.
• Analyze and evaluate field execution data to develop interim and final summary reports.
• Identify improvements observed during protocol execution to provide recommendations for SOP revisions.
• Review validation activities generated data to assure batch releases are not impacted.
• Document deviations identified during protocol execution to determine root cause, potential impact on product/process, and corrective/preventive actions. Inform / alert management of any unexpected results; call “DAI / Triage” meetings if necessary, to discuss findings and assess potential nonconformances.
• Design validation or qualification studies to ensure equipment and processes are suitable for the intended use.
• Create, review, revise, and approve documents including standard operating procedures, work instructions, test methods, equipment qualification and process validation protocol and final summary reports.
• Represent the Validation function in the review and approval of Change Controls involving equipment and processes.
• Coordinate scheduling of validation and qualification studies with area manager to ensure equipment, materials and personnel are available for performing studies.
• Prepare and oversee execution of validation protocols and reports in support of project schedule. Ensure site validation schedule is maintained.
• Coordination, direction, and oversight of teams supporting validation executions including technicians, mechanics, QA personnel, and vendor technicians.
• Analyze data from validation and qualification studies.
• Act as internal SME regarding validation topics.
• Provide training in process validation and equipment qualification for staff.
• Evaluate alternate or new technology to assist in validation studies.
• Participate in customer or regulatory audits as required. Follow-up on audit observations specific to the site validation function including assisting in the audit response and monitoring commitments specific to the related issues.

REQUIREMENTS

• Bachelor’s degree in Sciences/Engineering and at least 5 years of directly related experience on the Life Sciences industry (e.g. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy)
• Experience working on regulatory and compliance environments · Broad knowledge of current validation principles and industry practices including FDA and EU regulations, cGMPs, and validation guidance documents is required.
• Experience working on the qualification of sterilization equipment (autoclaves, tanks and vessels), utilities (HVAC, WFI system, PSG, CA), vial-filling line equipment (washer, tunnel, filling, capping, sealing), facilities including clean room is required.
• Experience working on airflow/smoke studies and thermal mapping is preferred.
• Familiar with quality engineering practices in manufacturing operations is required.
• Familiarity with variable and attribute sampling plans is required.
• Ability to independently plan and schedule validation activities.
• Proven ability to commit to and meet project deadlines is required.
• Able to work in a dynamic, multi-tasking and cross-functional environment.
• Good interpersonal skills to facilitate interaction among staff and project teams.
• Strong organizational skills with keen attention to details.
• Ability to make, describe and record observations, record and verify data, and analyze and assess validity of results.
• Proficient with Microsoft Office programs sufficient for composing memos, letters, and reports, develop spreadsheets for data graphing with and advanced Microsoft Excel functions required, Windows O/S, email, and related software applications such as Kaye Data Logger programming software.

PharmaLex is an Equal Opportunity Employer.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.