Job site is in St. Louis, MO. Local candidates preferred, but qualified candidates from other areas will be considered. Travel to the St. Louis client site will be from January through September 2020. Project includes travel to Germany.
Senior Validation Engineer
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.
- As part of Pharmatech’s consulting teams, provide validation services to clients in the regulated life sciences industry: pharmaceutical, biotech and medical device companies
- Perform a complete qualification of validation life cycle set of documents for an aseptic, automated assembly system
- Independently review system requirements to perform the following tasking:
- Review FAT and lead FAT execution in Germany in Spring 2020
- Resolve FAT testing issues to ensure acceptance of system to be shipped to USA
- Develop SAT protocol and prepare for execution in June 2020
- Lead SAT protocol execution resolve testing discrepancies, and route for approval
- Coordinate all validation activities by constant communication with affected departments and personnel
- Prepare IOPQ protocol and execute in timely fashion (current schedule calls for IOPQ execution
completion in August 2020.
- Final Performance Verification testing to be completed in September 2020
- Prepare final validation report, trace matrix
- B.S. with a scientific or engineering related major is required
- 5-15 years of validation work experience with demonstrated know-how of aseptic process equipment, automation system, facility and utility qualifications and project management
- Candidate must be able to work independently and possess stellar communication and coordination skills and prepare and execute timing dependent tasking.
- Candidate must be expert at developing and completing qualification of life cycle documents (URS, FAT, SAT, IOPQ, RTM) for aseptic automated systems. Familiarity with aseptic processing and validation of aseptic systems is required.
- Candidate is preferred to have diverse validation background to lend support to additional validation tasking at site.
- Must be able to work with minimal supervision in a fast-paced, annual shutdown environment
- Manage client relations
- Knowledge of Risk Assessment
- Proven ability to mentor and oversee junior validation engineers
- Experienced proficiency with GDP, GEP, GXP and cGMPS
- Outstanding communication (written and verbal) and interpersonal skills with the ability to work in a team environment is a must
- Excellent technical writing skill is critical
- Must be exceptionally motivation, able to work independently and function in a team environment
- Advanced computer skills and knowledge of Microsoft Office products required
- Willingness to work at various client sites both in and out of California with possible extended travel