Senior Pharmaceutical Validation Specialist

1 week ago

Lebanon, New Hampshire, United States Pharmavise Corporation Full time

About Us

Pharmavise Consulting Corporation is a leading regulatory compliance consulting firm partnering with Pharmaceutical, Medical Device and Biotechnology clients. Our mission is to ensure our clients exceed their compliance goals while improving patient health and safety.

Job Opportunity

We are seeking a highly experienced Senior Pharmaceutical Validation Specialist for a 12-month contract in Lebanon, Indiana. The successful candidate will lead the Commissioning and Qualification (C&Q) process within Good Manufacturing Practice (GMP) regulated environments.

Key Responsibilities

  • Manage the entire C&Q process, aligning cross-functional project teams and supporting continuous process improvement.
  • Provide guidance on using C&Q templates, drafting and updating critical C&Q plans.
  • Track and resolve C&Q action items, ensuring accurate documentation and compliance.
  • Offer expertise on validation standards (e.g., GAMP, ISPE, ICH) and regulatory requirements, including FDA regulations for medical devices and combination products.
  • Oversee document reviews and approvals, monitoring C&Q progress and reporting metrics.
  • Drive continuous improvement through process evaluations and maintain C&Q alignment.
  • Create a staffing model to support C&Q activities, manage support staff, and participate in essential project meetings.
  • Handle administrative tasks, engage in Design Review sessions and Site Acceptance Testing (SAT) activities.

Requirements

  • 10+ years of experience as a Commissioning & Qualifications Lead in a Pharmaceutical setting.
  • Bachelor's Degree or Advanced Degrees related to Engineering and Life Sciences.
  • Proficiency in validation for equipment and computer systems within GMP-regulated settings.
  • In-depth knowledge of external validation standards (GAMP, ISPE, and ICH) and regulatory requirements, particularly FDA standards for medical devices.
  • Exceptional communication skills and ability to guide team members and influence cross-functional stakeholders informally.
  • Demonstrated capability to work independently in a complex network environment.
  • Prior experience with automated equipment validation and managing large, cross-functional projects.
  • Strong understanding of how validation is impacted by modifications to equipment or systems.

Benefits

  • Salary: $120,000 - $150,000 per annum (dependent on experience).
  • Contract Length: 12 months.
  • Location: Lebanon, Indiana.
  • Set-up: Hybrid.
  • EEO Employer: Pharmavise Consulting Corp. is an equal opportunity employer.

About the Role

This role requires a deep understanding of validation practices for equipment and systems, along with the ability to align cross-functional project teams and support continuous process improvement. The successful candidate will be responsible for managing project deliverables, guiding the team on validation practices, and ensuring adherence to regulatory standards.

Travel Requirements

The successful candidate must be able to travel internationally and domestically to Original Equipment Manufacturers (OEMs) for design reviews, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT), including extended presence for entire review periods.

  • Automation Validation Specialist

    1 week ago

    Lebanon, New Hampshire, United States Pharmavise Corporation Full time

    OverviewWe are a regulatory compliance consulting firm, Pharmavise Corporation, partnering with Pharmaceutical, Medical Device and Biotechnology clients. Our mission is to ensure our clients exceed their compliance goals while improving patient health and safety.Our Fortune 500 Pharmaceutical client has an exciting opportunity for an Automation Validation...

  • Validation Specialist

    4 weeks ago

    Lebanon, New Hampshire, United States Pharmavise Corporation Full time

    Job SummaryWe are seeking a highly skilled Validation Engineer (Automation) to join our team at Pharmavise Corporation. As a key member of our regulatory compliance team, you will be responsible for ensuring equipment and automation systems meet compliance standards and operate effectively within Good Manufacturing Practice (GMP) guidelines.Key...

  • Commissioning and Qualification Lead

    4 weeks ago

    Lebanon, New Hampshire, United States Pharmavise Corporation Full time

    Pharmaceutical Commissioning and Qualification Lead OpportunityPharmavise Consulting Corp. is seeking a highly experienced Commissioning and Qualification Lead to join our team in Lebanon, Indiana. As a Commissioning and Qualification Lead, you will be responsible for managing the entire Commissioning and Qualification process within Good Manufacturing...

  • Senior Rehabilitation Specialist

    7 days ago

    Lebanon, New Hampshire, United States Heaven's Angels Services LLC Full time

    About the RoleWe are seeking a highly skilled Senior Rehabilitation Specialist to join our team at Heaven's Angels Services LLC. In this role, you will be responsible for providing expert assistance to patients, utilizing your knowledge of human anatomy and the musculoskeletal system.

  • Medical Logistics Specialist

    7 days ago

    Lebanon, New Hampshire, United States SDS Rx Full time

    Company OverviewAt SDS-Rx, we are committed to delivering high-quality pharmaceuticals and equipment to those in need. Our team of dedicated professionals is passionate about making a difference in the lives of our customers. Salary & BenefitsWe offer a competitive salary of $1000 per week, plus a $1,000 retention bonus for our delivery contractors. In...

  • Senior Clinical Nurse Specialist

    7 days ago

    Lebanon, New Hampshire, United States Dartmouth-Hitchcock Concord Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Nurse Specialist to join our team at Dartmouth-Hitchcock Concord. This is a unique opportunity for a dedicated and passionate nurse to make a meaningful impact in patient care.About the RoleThe Senior Clinical Nurse Specialist will be responsible for providing high-quality, evidence-based care to...

  • Senior Quality Assurance Specialist

    7 days ago

    Lebanon, New Hampshire, United States StarrTrax Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at StarrTrax. As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality and compliance across all aspects of our operations.

  • Senior Operating Room Nurse Specialist

    5 days ago

    Lebanon, New Hampshire, United States ALOIS Healthcare Full time

    Job Summary:We are seeking a skilled Senior Operating Room Nurse Specialist to join our team at ALOIS Healthcare. As a key member of our operating room team, you will be responsible for providing exceptional patient care and ensuring the smooth execution of surgical procedures.About Us:At ALOIS Healthcare, we value our nurses as brave warriors in scrubs who...

  • Senior Donor Communications Specialist

    3 days ago

    Lebanon, New Hampshire, United States Dartmouth College Full time

    Job OverviewDartmouth College is seeking a highly skilled and experienced Senior Donor Communications Specialist to join our team. This role will play a critical part in furthering the college's donor communication and stewardship opportunities.Key ResponsibilitiesDevelop and execute an annual comprehensive external relations strategy for Dartmouth College...

  • Medical Care Specialist for Seniors

    5 days ago

    Lebanon, New Hampshire, United States Abode Care Partners Full time

    Abode Care Partners: A Leading Provider of Integrated Medical ServicesAbout the Role:We are seeking a skilled Nurse Practitioner to join our team, providing evidence-based medical care to seniors and patients with complex needs. As a Medical Care Specialist for Seniors, you will be responsible for examining and treating various health issues, collaborating...

  • Senior Medical Care Specialist

    6 days ago

    Lebanon, New Hampshire, United States CenterWell Senior Primary Care Full time

    Work as a Primary Care PhysicianWe are seeking a skilled and compassionate Primary Care Physician to join our team at CenterWell Senior Primary Care. As a key member of our care team, you will play a vital role in delivering high-quality patient care and contributing to the overall well-being of our patients.About the JobWe offer a comprehensive compensation...

  • Senior Perioperative Nurse Specialist

    3 weeks ago

    Lebanon, New Hampshire, United States Dartmouth Health Full time

    Job Summary:The Senior Perioperative Nurse Specialist will play a key role in the Periop 101 program, a 9-month training period for nurses combining Association of peri-Operative Registered Nurses (AORN) approved online didactic learning with clinical skills labs and experiences in the Operating Room. This is a full-time, benefited...

  • Senior Neuropsychology Specialist

    1 week ago

    Lebanon, New Hampshire, United States Dartmouth Health Full time

    About the RoleWe are seeking a highly skilled Senior Neuropsychology Specialist to join our team at Dartmouth Health. As a key member of our multidisciplinary team, you will be responsible for delivering high-quality neuropsychological care to patients with complex neurological and medical conditions.About the PositionThis is a full-time position that...

  • Senior Neuromuscular Medicine Specialist

    1 week ago

    Lebanon, New Hampshire, United States Dartmouth Health Full time

    About the RoleWe are seeking an exceptional Senior Neuromuscular Medicine Specialist to join our team at Dartmouth Health, a leading academic medical center in Lebanon, NH. This is a unique opportunity to work with a highly integrated and cohesive healthcare system grounded in outstanding medical expertise.Job SummaryThe successful candidate will be...

  • Senior Neuro Oncology Specialist

    3 days ago

    Lebanon, New Hampshire, United States Enterprise Medical Recruiting Full time

    Enterprise Medical Recruiting Presents:A Dynamic Opportunity in Neuro OncologyAbout the RoleWe are seeking an accomplished Senior Neuro Oncology Specialist to join our esteemed medical center in New Hampshire. As a key member of our team, you will contribute significantly to research and clinical efforts.Key ResponsibilitiesPursue innovative research...

  • Senior Contract Strategist

    7 days ago

    Lebanon, New Hampshire, United States D-H Lebanon-MHMH Full time

    Job SummaryA strategic and experienced contract specialist is sought by D-H Lebanon-MHMH to lead the negotiation, management, and administration of complex contracts. As a key member of the procurement team, you will work closely with internal stakeholders to develop and implement effective contract strategies that align with business objectives.About the...

  • Polysomnographic Specialist

    3 days ago

    Lebanon, New Hampshire, United States D-H Lebanon-MHMH Full time

    About the RoleWe are looking for a dedicated Polysomnographic Specialist to join our team at D-H Lebanon-MHMH. As a member of our sleep center, you will play a vital role in ensuring the delivery of high-quality patient care.Your primary responsibility will be to perform Polysomnographic testing and associated interventions under the direction of a senior...

  • Senior Caregiver

    3 days ago

    Lebanon, New Hampshire, United States vTech Solution, Inc. Full time

    About the Role:We are seeking a skilled Senior Caregiver to join our team at vTech Solution, Inc. The ideal candidate will have at least 1 year of experience in long-term care and be comfortable working non-traditional hours.Key Responsibilities:Provide high-quality patient care in a long-term care settingCollaborate with healthcare teams to develop and...

  • Medical Care Specialist

    7 days ago

    Lebanon, New Hampshire, United States Abode Care Partners Full time

    Job OverviewWe are seeking a highly skilled Nurse Practitioner to join our team at Abode Care Partners. As a Medical Care Specialist, you will play a vital role in providing evidence-based medical care to seniors and patients with complex needs.

  • Senior Business Development Coordinator

    1 week ago

    Lebanon, New Hampshire, United States Wilson County Chevy Buick GMC Full time

    About Wilson County Chevy Buick GMCAt Wilson County Chevy Buick GMC, we pride ourselves on creating a work environment where our employees feel valued and supported. As a family-owned business, we understand the importance of teamwork and community. Our goal is to provide exceptional customer service while fostering a culture of growth and development.We are...