Validation Engineer

Are you interested in an exciting and rewarding career within a growing company? Are you eager to learn and motivated to collaborate with a team to achieve goals? Do you have passion for improving the lives of others?

Biovire (Formerly Bryllan) is looking for respectful, empathetic, courageous individuals who are eager to utilize their skills in a rewarding career. Bring the knowledge and experience you've gained from your education and career, along with willingness to continuously learn in the pharmaceutical manufacturing industry. Biovire (Formerly Bryllan) in Brighton, Michigan, is a contract manufacturing organization (CMO) with a focus in sterile injectable pharmaceuticals. Biovire (Formerly Bryllan) embraces a management philosophy built around the principles of Quality, Integrity, and Service. If you feel invigorated by the thought of contributing to the creation of life enhancing or lifesaving products, this opportunity could be for you!

Biovire (Formerly Bryllan) is hiring a Validation Engineer to oversee and maintain the qualification program. This program ensures that equipment used to manufacture pharmaceutical products is properly evaluated, qualified and is set onto a life cycle for continued operation within a controlled state. The role requires strong focus on technical writing, electrical / mechanical aptitude, a quality mindset, impeccable ethics and implementation of best practices / continuous improvement.

A Validation Engineer is a member of the Engineering team, responsible for all on-site equipment qualifications, as well as, partnering with external vendors / OEMs for new equipment / process qualifications.

Essential Duties and Responsibilities:

1. Ensures all equipment is maintained in a controlled state with critical process parameters in place to support the intended processes.
2. Author technical documentation required for the qualification / requalification of pharmaceutical process equipment.
3. Execute approved protocols to challenge current system abilities and corroborate operation with established operational parameters.
4. Addend protocols as necessary to incorporate new change parts or extended system performance requirements.
5. Coordinate throughout the equipment life cycle to ensure equipment is correct for the intended purpose and delivered on time to meet the manufacturing schedule.
6. Provide routine technical support and troubleshooting for resolution of equipment issues.
7. Act as assigned technical resource for manufacturing operations.
8. Participate in project teams for various new equipment needed in support of manufacturing activities.
9. Maintain the qualification library: IQ, OQ, PQ, qualification addendums and REQ documents maintaining GDPs.
10. Have a working knowledge of cGMP, industry standards and international guidelines.
11. Ensure work activities are conducted in strict accordance with safety guidelines and processing standards cGMP's and SOP's.
12. Analyze like-for-like and functional equivalent parts for replacement appropriateness.

Behavioral Expectations:

1. Strong work ethic and ability to accomplish tasks without supervision.
2. Knowledge of basic industrial safety standards and adherence to such during their daily assignments.
3. Demonstrate leadership both by words and leading by example to foster Biovire (Formerly Bryllan) One Team culture.
4. Capacity to manage multiple projects and deliver completed packages within a given timeline.
5. Excellent interpersonal skills with the ability to communicate effectively.
6. Basic computer skills (proficient in Microsoft Office applications).
7. Strong technical and organizational skills.
8. Excellent English communication skills, both written and verbal.
9. Must possess honesty and integrity, commitment to the highest legal and ethical standards.
10. Ability to treat every person with courtesy and respect.
11. Knowledge of cGMP and regulatory principles.

Work Experience and Education Requirements:

Minimum qualification of a four-year Degree in Engineering or Engineering Technologies.

Employment at Bryllan (Biovire) is contingent upon a successful Background check.

Salary : $65,000 - $75,000