Pharmatech Associates is a well-established, global consulting firm known for deploying technically superior, highly dedicated, professional project teams. Our Pharmaceutical, Biotech and Medical Device clients are located throughout the USA and Internationally.
We are looking for a Project Manager, GMP Operational Readiness to join our consulting team and provide project leadership. This is a salaried position with bonus and benefits, full-time staff position.
We’re looking for thought leaders who:
- Provide direct project management services on major GMP facilities including the asset induction, commissioning, validation, and GMP documentation phases.
- Assume responsibility for project execution, including coordination of technical information, field work, and contracted resources toward achievement of stated goals
- Possess established influencing abilities, sound judgment and the ability to act effectively/calmly with a high degree of independence.
- Simultaneously manage a variety of projects and bring them to completion on time, within budget, and safely with a quality mindset.
- Provide solutions to technical and scheduling conflicts. Identify, evaluate, and implement the use of technology and methods to improve Facilities and Operations. Remove roadblocks so others can complete their activities and achieve success.
- Encourage and interact with clients, developing new business relationships, goals and objectives.
- Coordinate scheduling and logistic plans and assume responsibility for the timely and efficient completion (Project Close-out) of project activities.
- Track and monitor scheduled activities weekly, utilizing Primavera P6 software.
- Compile and present monthly updates to client Senior Leadership regarding schedule forecasts, project status, accomplishments, project risks, and key business items requiring decisions.
- Oversee asset induction, calibration, commissioning, validation, and GMP documentation project phases. Facilitate weekly meetings, assuring safety and quality of all work performed.
- Develop and recommend long and short-range plans for improving project timelines to meet project milestones.
- Facilitate pull-planning and schedule Kaizen meetings.
- Track, update and/or expedite the flow of information, files, drawings, submittals, and correspondence in support of project activities.
- Participate in required GMP trainings and site-specific safety trainings.
- Schedule, facilitate, and distribute meeting minutes with assignable action items.
- Assist the project manager and construction team in coordinating the schedule of disruptive work and/or Commissioning testing.
- Manage and mitigate Project Risk (i.e., risk of the facility not being turned over on time, risk to project execution, risk of scope creep, etc.).
- Bachelor of Science Degree in Engineering or equivalent
- 8 – 12 years of GMP project management experience in a Pharmaceutical or Biopharmaceutical environment
- Project management experience of at least 2 relevant new construction or tenant improvement projects greater than $30M.
- Minimum 3 years’ experience as a Project Manager in a consultative role is required
- Strong understanding of asset induction, commissioning, process equipment validation, computer systems validation (CSV), GMP documentation required for system GMP release, and Change Controls.
- Understanding of system start up sequence
- Project Controls experience would be nice to have
- Strong understanding of process equipment: Reactors, filter dryers, isolators, + others
- Must have excellent demonstrated experience with scheduling software, preferably Primavera P6 software.
Client Work Environment
- Currently work remotely per COVID guidelines
- Expect 1 to 2 onsite visits per week.
About Pharmatech Associates
At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions. We are committed to fostering an environment that is professional and forth right. These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance. At Pharmatech talent matters, and we tackle each project with a “no fear” attitude. We stand together as a team, and we’ve got your back. Pharmatech’s commitment to integrity is unwavering.
Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.