Validation Team Lead
Location: St. Louis, MO USA
Experience: 7+ Years
Type: Contract or Permanent
Precision Scientific is currently seeking an experienced validation professional to lead a project team and manage project deliveriables. We would like to hear from you if you are looking for an opportunity to advance your career and grow your knowledge working with our team of validation and regulatory compliance professionals. Travel may be required with this position.
Qualified candidates must have strong technical knowledge of cGMP requirements as well as previous experience leading validation project teams. Must be an independent self starter with hands on experience qualifying process equipment and utilities associated with the manufacture of biologic drug substance and drug product (Bioreactors/Fermentors, Tanks, Centrifuges, TFF and Forward Flow Filtration, Chromatography Systems, WFI, Clean Steam, CIP, Process Gases).
Responsibilities:
The candidate will lead a team of validation professionals to provide equipment validation services in support of ongoing projects in the pharmaceutical and biotechnology industries. The validation team lead will be responsible for managing project deliverables, completing assigned tasks, attending project meetings, interacting with clients and updating management with project status. The validation team may be required provide hands on validation support services in addition validation team lead responsibilities.
Requirements:
Bachelor's degree in engineering, science, or related technology field,
Minimum of 7+ years of experience in validation, commissioning or engineering in the regulated pharmaceutical or biotechnology industries, including previous experience leading a validation project team,
Must have a strong background and understanding of cGMP requirements,
Strong written and oral communication skills,
Ability to travel for work as needed.
We offer a competitive base pay and benefit packages for our permanent employees. We offer competitive hourly rates to contractors.
Email Resume to careers@precision-sci.com
Equipment Validation Engineer - (Mid Level)
Location: Multiple Locations (St. Louis, Boston, Raleigh/Durham, San Francisco)
Type: Contract or Permanent
Experience: 3-5+ Years
Precision Scientific is currently seeking an independent and ambitious engineer with previous hands on validation experience in the regulated pharmaceutical or biotechnology industries. We would like to hear from you if you are looking for an opportunity to advance your career and grow your knowledge working with our team of validation and regulatory compliance professionals. Travel may be required with this position.
Qualified candidates must have experience qualifying process equipment and utilities associated with the manufacture of biologic drug substance and drug product (Bioreactors/Fermentors, Tanks, Centrifuges, TFF and Forward Flow Filtration, Chromatography Systems, WFI, Clean Steam, CIP, Process Gases).
Responsibilities:
The candidate will provide equipment validation services in support of ongoing projects under the direction of a validation team lead or project manager. The validation engineer will be responsible for completing assigned tasks, attending project meetings, interacting with clients and updating team lead with status of deliverables. The validation engineer may be required to work independently and/or in cross-functional teams.
Requirements:
Bachelor's degree in engineering, science, or related technology field.
Minimum of 3 years of experience in validation, commissioning or engineering in the regulated pharmaceutical or biotechnology industry.
Must have a strong background and understanding of cGMP requirements.
Strong written and oral communication skills.
Ability to travel for work as needed.
We offer a competitive base pay and benefit packages for our permanent employees. We offer competitive hourly rates to contractors.
Email Resume to careers@precision-sci.com
Senior Process Validation Specialist
Location: Multiple Locations (Philadelphia, Boston, Baltimore/D.C. Metro, Raleigh/Durham, St. Louis)
Type: Contract or Permanent
Experience: 5+ Years
Precision Scientific is currently seeking an independent and ambitious process validation expert with experience in the manufacture of biologic drug product and sterile parenterals in the regulated pharmaceutical or biotechnology industries. We would like to hear from you if you are looking for an opportunity to advance your career and grow your knowledge working with our team of validation and regulatory compliance professionals. Travel may be required with this position.
Qualified candidates must have hands on experience with the successful completion of process validation and aseptic process simulations projects for biologics and sterile parenterals.
Responsibilities:
The candidate will provide process validation services in support of ongoing projects under the direction of a validation team lead or project manager. The senior process validation specialist will be responsible for developing process validation strategy, completing assigned tasks, attending project meetings, interacting with clients and updating team lead with status of deliverables. The senior process validation specialist will be required to work independently and in a cross-functional team.
Requirements:
Bachelor's degree in chemical or biological engineering, science, or related technology field.
Minimum of 5 years of experience in validation, with direct process validation of biologics and sterile parenterals in an aseptic environment.
Must have a strong background and understanding of cGMP requirements.
Strong written and oral communication skills.
Gene therapy experience is a plus.
Ability to travel for work as needed.
We offer a competitive base pay and benefit packages for our permanent employees. We offer competitive hourly rates to contractors.
Email Resume to careers@precision-sci.com
Computerized System/Data Integrity Validation Engineer
Location: St. Louis, MO USA
Experience: 3-5+ Years
Type: Contract or Permanent
Precision Scientific is currently seeking an engineer with previous validation experience in the validation of complex computerized systems in the regulated pharmaceutical or biotechnology industries. We would like to hear from you if you are looking for an opportunity to advance your career and grow your knowledge working with our team of validation and regulatory compliance professionals. Travel may be required with this position.
Qualified candidates must have experience with data integrity requirements and the validation of complex computerized systems in the regulated pharmaceutical and biotechnology industry.
Responsibilities:
The candidate will provide computerized system validation services in support of ongoing projects under the direction of a validation team lead or project manager. The validation engineer will be responsible for completing assigned tasks, attending project meetings, interacting with clients and updating team lead with status of deliverables. The computerized system validation engineer will be required to work independently and/or in cross-functional teams.
Requirements:
Bachelor's degree in engineering, science, or related technology field.
Minimum of 3 years of experience in validation of complex computerized systems in the regulated pharmaceutical or biotechnology industry.
Must have a strong background and understanding of data integrity and cGMP requirements.
Strong written and oral communication skills.
Ability to travel for work as needed.
We offer a competitive base pay and benefit packages for our permanent employees. We offer competitive hourly rates to contractors.
Email Resume to careers@precision-sci.com