Senior Validation Engineer

Job ID: | Position Type: Full-time, Exempt

location

San Francisco Bay Area

Pharmatech Associates is a well-established, global consulting firm located in the San Francisco bay area.   We are known for deploying technically superior, highly dedicated, professional project teams.

We are looking for an exceptional senior level validation engineer to join our consulting team providing validation services to clients in the regulated life sciences industry.  If you enjoy travel, some of our pharmaceutical, biotech and medical device company clients are located outside of the San Francisco Bay Area.  This is a salaried position, full-time, at client sites and responsible for coordination, execution and management of validation deliverables for equipment, critical utilities and processes.

A typical day as Senior Validation Engineer includes:

  • Preparing and executing protocols for equipment, facility, utility, and cleaning validation work (IQ, OQ, PQ, & DQ)
  • Performing validation master planning and leading validation strategic planning efforts
  • Developing and revising new or existing procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations.
  • Providing technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control
  • Recommending improvements in policies and procedures, to enhance the ability to conform to and maintain compliance with site, corporate and regulatory standards.
  • Coordinating validation activities by constantly communicating with affected departments and personnel
  • Managing client relations
  • Directing and supporting junior level engineers

What you’ll like most about working with our Validation & Commissioning 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 for career growth.
  • 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.

We’re looking for candidates who:

  • Earned a bachelor’s degree in engineering or life sciences
  • Have 7+ years’ experience in the regulated life sciences industry with 5 years of progressive experience in validation
  • Exhibit above-average proficiency with cGMPs, GDP & GEP
  • Thoroughly understand the validation life cycle and are experienced with IQ, OQ, PQ, DQ protocol generation and execution
  • Demonstrate a know-how of solid dosage process equipment, automation system, facility and utility qualifications and project management
  • Display exceptional communication (written and verbal) and interpersonal skills
  • Are motivated, with the ability to work in a team environment or effectively work independently at client sites
  • Can travel domestically and overnight to client project sites
  • Easily and efficiently use the suite of Microsoft Office products

Preferred qualifications:

  • Experience working for a consulting firm
  • Project Management Experience
  • Cleaning Validation experience
  • Computer Systems Validation Experience

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.

 

EEOC Statement:

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.