Summary
DPS Group is seeking a Quality Assurance Validation Engineer in Alachua, FL. Candidates should have a strong understanding of the engineering lifecycle related to biotech and pharmaceutical GMP industries.
Responsibilities
- Collaborate with cross-functional departments to maintain and enhance compliance.
- Review and approve validation documentation- such as user requirements, functional requirements, validation plans IQ/OQ/PQ documentation, risk assessments, test scripts, decommissioning / recommissioning checklists, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)
- Responsible for QA oversight on the development and implementation of Quality, Manufacturing and laboratory systems/processes to facilitate new projects and continuous improvement activities
- Observe commissioning and/or qualification execution as-needed.
- Collaborate with global, cross functional teams to accomplish objectives and team goals including but not limited to, on -time completion of system go-lives and enhancements
- Review and approve deviations, change controls, system periodic reviews and CAPAs
- Other duties as assigned
Skills and Qualifications
- 3+ years experience working in GMP manufacturing facilities role
- Bachelor’s degree or equivalent in engineering, science or related discipline
- Experience in Biotechnology, Cell/Gene Therapy, and/or Novel Therapy cGxP environment
- Combination of equipment qualification, process validation, computer systems, cleaning and sterilization. Quality Assurance in biotechnology and/or pharmaceuticals preferred
- Quality experience with in-depth knowledge of validation approach, cGxP standards and risk-based validation
- Direct experience in commissioning, qualification and validation of facilities, utilities, production, laboratory and support equipment
- Knowledge of industry guidelines (ISPE, PDA) US and international regulation (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities
- Must have strong verbal, written and interpersonal communication skills especially needed to work in cross-functional environment
- Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
- Must be capable of aseptic gowning into the cleanroom environment.
Additional Skills Required:
In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to high technical standard. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
- Culture – Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
- Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
- Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
- Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.
- Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
- Language Ability – Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
- Mathematical Ability – Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
- Reasoning Ability – Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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