THIS ROLE WILL REQUIRE New Hampshire RELOCATION
Full-Time Permanent Position
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Senior Process Engineer – Pharmaceuticals
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Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel (Full-Time Permanent Positions). This company has the experience, expertise, and a successful track record in completing the development of life-changing pharmaceuticals and medical devices. Together with their clients, they work to bring about the treatment of many forms of cancers, diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.
Job Summary
The Process Validation Engineer III/IV performs an array of well-defined validation/qualification activities in support of cGMP pharmaceutical/medical device contract manufacturing across multiple facilities. These PV activities include working with clients to define process control parameters and design protocols to test and verify process robustness. The role requires audit and inspection management support. In collaboration with validation management, assist internal project teams and external validation firms on validation/qualification initiatives and to ensure project schedules are met. Complies with the requirements of the Safety Program, including Health and Safety mandates and OSHA requirements. In carrying out duties, PV Engineer contributes and promotes a positive and equitable working environment emphasizing the company Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
Essential Functions
- Author Process qualification/ verification validation plans; this includes the development of client specific process requirements and specifications drafts to execute process performance qualifications, process simulation media fill protocols. Also compile trace matrices, perform data analysis, draft validation protocol discrepancy reports and draft process validation summary reports
- Author and perform the technical review of deviations and planned deviations, change controls, perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes
- Participate in client and Regulatory Audits. Work on CAPA and Deviations with minimal but some oversight to achieve quality, timely results
- Assist with determining impact of change control on qualified process and aseptic operations.
- Work closely with other validation department personnel and cross-functionally with MTS, Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables.
- Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation. Perform all functions associated with process validation support.
- Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
- Perform risk assessment and mitigation steps to achieve validation requirements and ensure each process remains in a validated state of compliance by compiling and analyzing data for continued process verification.
- Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping the manager updated regularly.
- Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping teammates and manager informed and providing guidance to other engineers as needed.
- Write process validation and process simulation media fill protocols and technical study approaches.
Experience Requirements
- Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments.
- Skilled in the development and execution of PPQ’s. Review commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
- Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
- Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization, Steam Sterilization, data analysis and statistics.
- Engagement and know-how with regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes.
Education and Skills
- Bachelor of Science degree in Chemical Engineering, Biochemistry, Biology or related scientific discipline required with a minimum of 6 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, MTS, Process Development or Engineering.
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
- Possess strong knowledge of Process Performance Qualification /Validation practices, including applicable regulations.
- Excellent technical writing, verbal communication, and presentation skills.
- Proficiency in Microsoft Office including Word, Excel, Power Point, Project
Physical Requirements and Mental Demands
- Ability to lift 50 pounds
- Must be able to stand for long periods of time each day
- Travel and work at all site locations/facilities
- Ability to multitask with competing demands and at times shifting priorities.
- Able to don ISO cleanroom gowning and PPE, as required by site procedures.
Communciation Requirements
- Interacts with all department staff to resolve technical issues and initiate process improvements.
- Must be able to work with clients and multiple departments including Operations, MTS, Engineering, Facilities, Quality Control and Quality Assurance.
Job Type: Full-time
Pay: From $1.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Parental leave
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
Supplemental Pay:
- Bonus pay
- Signing bonus
Application Question(s):
- Will you now, or in the future require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?
- Are you willing to relocate to New Hampshire?
Experience:
- Pharmaceutical: 5 years (Preferred)
- Process Engineer: 5 years (Preferred)
Work Location:
- One location
Work Remotely:
Source: Indeed.com
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