PURPOSE 

Primary role is to lead Quality Control laboratory operations to ensure compliance with cGMP, FDA, and regulatory requirements in support of pharmaceutical manufacturing. This role provides leadership and direction to the Quality Control team in testing, data integrity, approval and release of raw materials, in-process samples, intermediates, and finished drug products.

REPORTS TO

Reports to the Quality Control Manager and oversees a team of Quality Control Chemists and Technicians. This position will also interact with other departments including Quality Assurance, Analytical/ Stability, API, Research & Development, Business Development and outside vendors.

DUTIES AND RESPONSIBILITIES

Laboratory Operations

• Ensure a safe working environment by providing leadership on all safety-related issues in the quality and microbiology laboratories at the Round Rock site.
• Be an active champion for good housekeeping, cGMP and safety related issues.
• Maintain and develop strategy for the analytical equipment and instrumentation in both labs.
• Ensure the spare parts program is in place for instrumentation.
• Ensure analytical methods are maintained and validated.
• Coordinate internal and external laboratory tests, procedures and methods and the development of new product test methods and specifications in conjunction with manufacturing, marketing, product development and sales functions.
• Ensure that all finished product meets appropriate internal specifications to ensure customer satisfaction.
• Handle special projects assigned for method validations or equipment qualifications.
• Ensure necessary supplies are ordered and stocked for the laboratory operations.

Leadership & Team Development

• Supervise the quality department chemists, analysts, and technicians. Manage in accordance with the organization’s policies and applicable laws.
• Mentor and train employees; planning, assigning, and directing work.
• Support employee development through training and performance management.
• Managing complaints and resolving performance and collaboration issues.

Compliance & Documentation

• Ensure laboratory operations comply to relevant standards: GMP, GDP, ISO 9001:2015.
• Ensure instrumentation is compliant with current standards and follows recommended calibration frequencies and/or replacement schedules.
• Ensures proper compliance to OOS program and proper investigations are completed and documented.
• Participate in internal audits and conduct audits of the laboratory operations to ensure compliance is demonstrated.

Continuous Improvement

• Identify opportunities for process improvements within the laboratory.
• Implement efficiency initiatives and best practices.
• Support method validation, method transfer, and analytical troubleshooting.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Bachelor’s degree or higher in a Life or Chemical Science; Chemistry, Analytical Chemistry or similar science-based degrees preferred.
• Minimum of 5 years in Quality Control within a pharmaceutical, chemical or manufacturing environment with a minimum of 2-5 years of experience in a supervisory or management role.
• Strong knowledge of cGMP, FDA, ICH, and USP requirements
• Hands-on experience with HPLC, GC, spectroscopy, wet chemistry, and other analytical techniques.
• Demonstrated ability to lead and develop teams and resolve conflicts in support of organizational goals.
• Strong interpersonal skills: demonstrated ability to work effectively, professionally, and respectfully in a team-based environment to involve peers, customers, line management and technical competency experts.

WORKING CONDITIONS / PHYSICAL REQUIREMENTS  

• Ability to stand for up to 8 hours per day.
• Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening.
• Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping.
• Occasional lifting and/or moving up to 50 pounds.

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time.

Positions posted for Benuvia Operation are not intended for or open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.

PURPOSE 

Primary role is to supports manufacturing and quality operations to ensure compliance with cGMP, FDA, and applicable regulatory requirements. This role is responsible for maintaining and improving quality systems, supporting investigations and CAPAs, and partnering with cross-functional teams to ensure the consistent manufacture and release of high-quality pharmaceutical products.

REPORTS TO

Reports to the Quality Control Manager and supports the Quality Control organization. This role will interact with cross-functional departments including Manufacturing, Research and Development, Analytical Development, Quality Assurance, and Facilities, as well as external vendors and service providers, to support Quality Control operations, equipment, and quality system activities.

DUTIES AND RESPONSIBILITIES

• Author, execute, and maintain equipment qualification protocols and reports (IQ/OQ/PQ as applicable) in support of Quality Control laboratory operations.
• Author, execute, and maintain cleaning validation protocols and reports for equipment and laboratory areas, ensuring compliance with cGMP and internal requirements.
• Support the Quality Control organization in the management of quality system records, including change controls, CAPAs, deviations (DEVs), and out-of-specification (OOS) investigations, ensuring timely, thorough, and compliant documentation.
• Participate in and support root cause investigations, risk assessments, and the development of effective corrective and preventive actions.
• Coordinate with internal stakeholders and external vendors to ensure laboratory equipment calibration activities are completed accurately and within required timelines.
• Develop, revise, and maintain SOPs, work instructions, and processes related to equipment qualification, validation, calibration, and quality systems.
• Provide quality engineering support to operations to maintain a state of control and readiness for internal, client, and regulatory inspections.
• Review and assess the impact of proposed changes on systems, equipment, and processes, and support implementation through the change control process.
• Ensure documentation and activities comply with cGMP, FDA regulations, data integrity principles, and company policies.
• Collaborate cross-functionally with Quality Assurance, Manufacturing, R&D, Analytical development, and other stakeholders as required to support company objectives.
• Identify opportunities for process improvement within quality systems and contribute to continuous improvement initiatives.

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Bachelor’s degree or higher in a life or chemical science; chemical engineer, chemistry, analytical chemistry, or a similar science-based degree preferred.
• Minimum of five years of experience in Quality Control within a pharmaceutical, chemical, or manufacturing environment, with at least two years of experience in a validation or quality engineering role.
• Strong knowledge of cGMP, FDA, ICH, and USP requirements.
• Hands-on experience with analytical techniques.
• Strong technical writing skills with a quality-oriented mindset, and a proven ability to author and execute protocols in laboratory and manufacturing environments.
• Strong interpersonal skills, with a demonstrated ability to work effectively, professionally, and respectfully in a team-based environment, and to collaborate with peers, customers, line management, and technical subject matter experts.

WORKING CONDITIONS / PHYSICAL REQUIREMENTS

• Ability to stand for up to 8 hours per day.
• Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening.
• Occasional climbing ladders/steps, walking up inclines and uneven terrain, reaching with hands and arms, stooping, kneeling, crouching, crawling, twisting, bending, handling, turning, balancing, carrying, grasping.
• Occasional lifting and/or moving up to 50 pounds.

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time.

Positions posted for Benuvia Operation are not intended for or open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.

PURPOSE

Primary Role is to support the manufacturing and process development initiatives for a cGMP pharmaceutical facility.  Position will provide technical and maintenance support for Facilities/Utilities Infrastructure, Active Pharmaceutical Ingredients (API) plant processes (Reactions and Purifications) and/or Finished Drug product manufacturing (Compounding, Filling, and Packaging).

Under general supervision and according to prescribed procedures, plans and performs electrical/mechanical installations and validations, prescheduled and emergency maintenance of electrical/mechanical applications.  Will be expected to assist in developing maintenance procedures for assigned area(s).

After a suitable training period, this individual must demonstrate an understanding of the equipment and processes assigned to include production equipment, process stages, control systems, and plant utility services. Will be expected to track and trend production data, identify and implement process and/or equipment improvements that will improve business measures and/or increase overall equipment reliability.

Will be expected to assist in investigating both in-process and field product complaints as well as the development and implementation of appropriate corrective actions as assigned.

Continuous running operations are expected and will require this position to be flexible to after-hours support roles as assigned.

REPORTS TO

Reports to the Director of Facilities and Maintenance Engineering and will have interactions with members of other departments including Quality Control, Analytical/Stability, Manufacturing, Quality Assurance, Validation, Research & Development, and outside customers.

DUTIES AND RESPONSIBILITIES

• Electrical installation, troubleshooting, and repair from 24VDC up to 3 phase 480VAC.
• Mechanical installation, troubleshooting, and repair.
• Maintain and Support Production Processes.
• Proactively ensure equipment is maintained to minimize disruption to production schedules.
• Perform preventative and correctional maintenance in accordance with SOPs and equipment manuals.
• Service chillers, boilers, generators, pumps, compressors, motors, fans, belts, and related equipment.
• Troubleshoot, diagnose, and repair issues with HVAC systems, refrigeration/freezer units, and related equipment.
• Keep current on all required training and SOPs.
• Assist in maintaining a clean laboratory.
• Adhere to safety protocols and policies.
• Ensure cGMP documentation is followed.
• Perform qualifications on cGMP equipment/processes as necessary.
• Assists in reviewing SOPs and other relevant documentation.
• Plan and execute new or existing equipment projects as assigned.
• Keep Engineering and Operations informed of process issues and plans to resolve these issues.
• Provide support for Deviation’s and CAPA’s for assigned area(s).

QUALIFICATIONS (Education, Experience, Knowledge, and Skills)

• Relevant Work Experience or an associate degree in industrial maintenance, Industrial Systems, Instrumentation, Electrical Systems, Electronics, HVAC or similar field preferred.
• Minimum of 3 years’ work experience, in a cGMP pharmaceutical/medical device environment and FDA regulated experience – Highly Preferred.
• Have in-depth knowledge of electrical, HVAC, hydraulics, mechanical, and automation control systems.
• Ability to read and interpret electrical/mechanic schematics.
• Have in-depth knowledge of EHS (Environmental, Health and Safety).
• Strong HVAC experience a plus.
• Must be detail oriented, self-motivated, and able to multi-task in a production environment.
• Must be able to create and follow written procedures relevant to assigned tasks.
• Strong planning skills and project management skills.
• Must have effective written and verbal English communication skills.
• Work hours must be flexible to meet production timelines.
• Drug screen and DEA background check required.

WORKING CONDITIONS/ PHYSICAL REQUIREMENTS

• Must have no physical limitations that would prevent:
  • Able to periodically lift 50 pounds or more
  • Able to climb a ladder
  • Able to wear a full-face respirator
• During certain operations, the worker will be required to wear a full-face respirator and perform physically strenuous activity for extended periods of time
• The worker will be in an environment with electrical, chemical, explosion, fall, drop, and trip hazards
• The worker will be required to handle controlled substances and work in the presence of hazardous materials with appropriate PPE, including those that are:
  • Flammable/Explosive
  • Carcinogenic
  • Oxidizing agents
  • Respiratory hazards
  • Highly acidic/basic
  • Under high pressure
  • At high temperature
  • Halogenated solvents
  • Organic materials

LOCATION

This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin.

TO APPLY

If you are interested in joining the Benuvia team, please SUBMIT YOUR RESUME below with your salary requirement.

Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time.

Positions posted for Benuvia Operation are not intended for or open to third party recruiters or agencies. Unsolicited resumes for these positions will be considered to be free referrals.