Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams.  Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.   We are looking for a Sr. Validation Engineer/CQV to join our consulting team and provide market leadership, develop and execute science based clinical and regulatory solutions for the Life Science industry.  This is a long term contract position located in N. San Diego area with opportunity to convert to a full time role if desired. We’re looking for thought leaders who:

• The Sr. Validation Engineer/CQV, Commissioning, Qualification and Validation will provide CQV services to clients in the Life Sciences Industry and perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project scope.
• Follows client standards and regulatory requirements, overall good industry practices for commissioning, qualification and validation (CQV) services.
• This position is primarily responsible for execution of validation activities to drive overall quality and compliance at the assigned client’s facilities and may be part of a larger team executing a specific project scope or may act in a staff augmentation role by executing a variety of validation deliverables.
• General validation support for equipment installations and modifications.
• Key skills include creating commissioning and qualification documentation (commissioning and IQ, OQ and PQ protocols), executing commissioning and qualification activities including temperature mapping, authoring summary reports, and supporting any other validation needs related to the project.

KEY ACTIVITIES AND RESPONSIBILITIES

• Participate in project teams executing various validation projects under the direction of a project manager or validation lead.
• Participate in issue identification, investigation and mitigation.
• Provide routine progress and issue updates to project team.
• Participate in client Validation teams in executing routine Validation deliverables.
• Be responsible for the development of documentation to support commissioning.
• Write final reports for IQs, OQs and PQ Protocols for facility, utility, and process equipment.
• Perform commissioning, qualification, and validation testing on manufacturing process equipment and instruments; authors protocols, initiates controlled documentation, and provides client support for CQV projects either independently or as part of a larger team.
• Responsibilities may include generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and development and development of final reports.
• The position requires extensive interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements.
• Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
• Investigates failures and deviations; creates reports
• Analyses and reviews spare parts lists to ensure they are fit for purpose
• Reviews engineering drawings for accuracy and acts to correct errors
• Performs system walk-downs and makes changes using the change control of processes
• Initiates and resolves client Corrective and Preventative Actions (CAPAs)
• Expert understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
• Exceptional writing skills required to author and execute DQ, FAT, SAT, IQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines
• A thorough and working knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes
• Ability to provide self-direction and work independently or on a team
• Analytical, organizational, time management and problem-solving skills
• Take a proactive role in supporting CQV projects and in providing client support and build a high level of trust personnel.

QUALIFICATIONS

• Bachelors degree in a chemical, biomedical or biochemical engineering, biological sciences, or related field plus a minimum of 7 years relevant industry experience
• Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices is required
• Strong experience with CQV (Commissioning, Qualification, Validation) and quality System/Life Science manufacture industry experience is required.
• Have solid experience supporting commissioning and qualification projects in the life sciences industry.
• Understanding of GMP production facility utilities and their application, such as Water for Injection (WFI), Cleanroom Environments (HVAC), Clean Steam and process gases.
• Experience in temperature mapping is preferred
• Subject Matter expertise in the following areas:

 

• Manufacturing and utility systems
• Facility qualification
• Equipment qualification

 

• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Able to function efficiently and independently in a fast paced, changing environment.
• Able to function and contribute as part of a team.
• Possess excellent interpersonal, verbal and written communication skills.

  What you’ll like most about working with our team at Pharmatech Associates:

• Everyone at Pharmatech Associates contributes to the success of our projects, departments and company.  Your input will not only be heard; it will be encouraged and valued.
• We are consultants, and you will move from project to project.  You will have endless opportunities to learn and grow your career.
• Your coworkers are a group of highly intelligent and motivated employees.  There will always be someone in-house that has done the job you were hired to do, and you will be able to learn from them.
• We take great pride in offering our employees the best benefits and competitive compensation packages in our industry, plus performance-based bonus incentives.
• Fantastic co-workers and no internal politics!  A culture that thrives on true collaboration.

About Pharmatech Associates   At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions.  We are committed to fostering an environment that is professional and forth right.  These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance.  At Pharmatech talent matters, and we tackle each project with a “no fear” attitude.  We stand together as a team, and we’ve got your back.  Pharmatech’s commitment to integrity is unwavering. Apply:  Please send your resume to careers@pai-qbd.com