Technical Services Associate
SUMMARY / OBJECTIVE
A Technical Services Associate is responsible for collecting samples, taking measurements, analyzing data, writing reports in support of manufacturing, commissioning, qualification, and validation (CQV) activities at Sovereign Pharmaceuticals. Includes creating and reviewing technical documents e.g., SOPs, equipment documentation, and other supporting materials), issuing and managing document change controls to ensure efficiency and compliance. The role requires them to be familiar with the validation requirements associated with a pharmaceutical manufacturing facility.
ESSENTIAL FUNCTIONS
? Collect samples, take measurements, analyze data, write reports in support of manufacturing and Technical Services activities.
? Supports activities relating to validation project execution for equipment, critical utilities, automated systems, software, cleaning validation, and process validation according to written SOPs and protocols.
? Ensures that their execution of protocols, records, and procedures is compliant with current Good Manufacturing Practices (cGMP), Good Automated Manufacturing Practice (GAMP), and Sovereign’s SOPs.
? Interact with technical associates, leads, and subject matter experts (SMEs) from other departments and divisions to create and revise GMP documents, such as procedures for cleaning manufacturing and packaging equipment.
? Prepare, write, update, and maintain manufacturing SOPs and FORMs where applicable, including the preparation of any forms or attachments that may accompany the SOP.
? Able to read and understand specifications (design requirements, functional requirements, and user requirements), trace matrices, validation summary reports, and test protocols for installation, operation, and performance qualifications.
? Familiar with regulations and guidance’s (e.g., 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, ICH, ISPE, PDA, MHRA, PICs).
? Versed in the concepts of data integrity and statistical treatment of experimental data. Can, with supervision, recognize laboratory data that is compliant to applicable regulations and meets study protocol acceptance criteria.
? Able to summarize experimental data for populating technical reports.
WORK ENVIRONMENT
This job operates in a professional office, laboratory, and manufacturing environments. The attire is dictated by the environment that you are working in (e.g., business casual attire for the office). This role routinely uses specialized equipment and instruments for obtaining samples and testing the functions of manufacturing equipment in support of validation activities. Standard office equipment and software is also routinely used.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee may be required to sit at a computer or be on their feet for long periods of time. The duties will require working around and on manufacturing equipment requiring bending, squatting, climbing, and reaching above shoulder level. There are specific vision abilities, manual dexterity, and fine finger movement required by this position for Process Validation activities. This job requires the need to be able to lift fifty (50) pounds.
POSITION TYPE / EXPECTED HOURS OF WORK
This is a full-time position. Days and hours of work are Monday through Friday but extended (earlier or later) work times or weekend work may be required. Validation activities require flexible hours to meet the manufacturing schedule.
REQUIRED EDUCATION AND EXPERIENCE
? High School Diploma or General Educational Development Test (GED) with at least three years of pharmaceutical manufacturing experience. Experience with validation, qualification, and commissioning experience in the pharmaceutical industry is preferred.
? Demonstrated experience with the execution of documentation including validation documentation, technical protocols, and technical reports.
? Demonstrated ability for supervised work that requires multi-tasking and a high level of attention to detail.
? Demonstrated ability to be an active participant on teams.
? Knowledge of FDA Current Good Manufacturing Practices (cGMP).
? Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).
PREFERRED EDUCATION AND EXPERIENCE
? Degree (BA/BS) in a technology-related field (Biology, Chemistry, Pharmacy, Engineering, etc.) with validation, qualification, and commissioning experience in the pharmaceutical industry.
? Has basic knowledge of the key scientific, technical, and regulatory challenges associated with the manufacture of non-sterile pharmaceutical solid and liquid oral-dosage-forms.