Pharmaceutical Manufacturing Facilities – Staff Augmentation

The challenge

In today’s economy the ability to staff engineering technical services for the life science industry is complicated by management’s desire to minimize fixed expenses (headcount), to do more with less, and the inability to replace existing employees in order to minimize cost. The need for staff augmentation may be short or long-term depending on the circumstances.

The solution

Performance Validation has provided the life science industry with qualified professionals who have provided both short and long-term staffing solutions. For example, at several large Midwestern pharmaceutical and medical device manufacturing facilities:

Performance Validation was requested to provide an experienced engineer to take on the role of a building engineer of an API manufacturing facility. The individual provided a long term solution filling the building engineer role for over 7 years.

Performance Validation was requested to provide an experienced verification project manager. This was a six month role, which has since been extended. Responsibilities include determining the verification strategy for engineering projects, defining the verification scope, and serving as an independent verification reviewer representing the engineering organization for the client. In addition to the verification responsibilities PV was also asked to review and revise guidance documentation and SOPs, audit executed verification documents to ensure that the verification program is being implemented in accordance with the approved guidance, and to stage documentation for customer audits.

Performance Validation was requested to provide an experienced HVAC engineer to assist an API facility in the management of the facilities HVAC systems. Responsibilities included maintaining HVAC equipment to provide both human comfort and cGMP required air quality as dictated by the manufacturing area to maintain their qualified state for ISO 8 suites, chill rooms and freezers. The role has expanded to a Plant Engineering role to also include other building utilities such as steam, chilled water, glycol systems, compressed gases, and potable water/waste systems. Plant engineering provides resources and guidance to help reduce energy costs and implement strategies to constantly improve and maximize the facilities resources. This individual provided a long-term solution, currently serving in this role for 2-years to provide a stable and consistent resource for the facility.

Performance Validation was requested to provide two experienced validation specialists to assist with protocol development and execution of pharmaceutical manufacturing equipment. This is a three month role with three month renewals. Responsibilities include change control support, development and execution of cleaning validation and qualification protocols, and participation in quality system activities such as audit support or lessons learned activities.

The Results

Performance Validation staff serving in a staff augmentation role have been able to add significant value to our clients and have received numerous accolades and positive feedback on their performance. Through the use of contracted resources, our clients were able to meet their mission requirements without increasing overall fixed costs. Using Performance Validation staff (full time employees with benefits) can eliminate co-employment concerns.

For further information:
Brad Henry
Vice President, Performance Validation
Cell (317) 727-8495